A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01920061
• Collaborator: (none)
• Enrollment: 110
• Locations: 29
• Arms: 5
• Actual Duration (Months): 75.9
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Drug: PF-05212384 (gedatolisib); Drug: Docetaxel; Drug: Cisplatin; Drug: Dacomitinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1B OPEN-LABEL THREE-ARM MULTI-CENTER STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF PF-05212384 (PI3K/MTOR INHIBITOR) IN COMBINATION WITH OTHER ANTI-TUMOR AGENTS
• Actual Study Start Date: Sep 10, 2013
• Actual Primary Completion Date: Jan 8, 2020
• Actual Study Completion Date: Jan 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A	Drug: PF-05212384 (gedatolisib); PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle; Drug: Docetaxel; Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental: Arm B	Drug: PF-05212384 (gedatolisib); PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle; Drug: Cisplatin; Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental: Arm C	Drug: PF-05212384 (gedatolisib); PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle; Drug: Dacomitinib; Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
Experimental: Expansion Arm 1	Drug: PF-05212384 (gedatolisib); PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle; Drug: Cisplatin; Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
Experimental: Expansion Arm 2	Drug: PF-05212384 (gedatolisib); PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle; Drug: Cisplatin; Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C [Up to 21 days]

   DLT was defined as any of the following adverse events (AEs) attributable to the combination: (1) hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia; grade >=3 neutropenia with infection; grade 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=2 pneumonitis; grade>=3 toxicities, except pneumonitis, and excluding those that had not been maximally treated; persistent, intolerable toxicities which resulted in the failure to deliver at least 3 of the 4 doses of PF-05212384 for Arms A and B or at least 3 of the 4 doses of PF-05212384 and 75% of dacomitinib for Arm C during the first cycle; the persistent, intolerable toxicities which result in delay of the start of the second cycle by more than 2 weeks relative to the scheduled start; in an asymptomatic participant, the grade 3 QTc prolongation persists after correction of any reversible causes.

2. Percentage of Participants With Objective Response - Arm B Expansion [Cycle 1 Day 1 up to 18 months]

   Percentage of participants with objective response based on the assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

Secondary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.

2. Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.

3. Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   Laboratory abnormalities were graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: anemia,hemoglobin increased, platelets, white blood cells, absolute neutrophils,lymphocyte count increased, lymphopenia.

4. Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: partial thromboplastin time and prothrombin time international normalized ratio(INR).

5. Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), total bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia.

6. Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis [From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

   Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameter was analyzed for laboratory examination: urine protein.

7. Number of Participants With Vital Signs Data Meeting Pre-defined Criteria [From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment). Maximum duration between first and last dose: 842 days.]

   Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position.

8. Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.]

   Cmax is defined as maximum observed plasma concentration.

9. Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.]

   Cmax is defined as maximum observed plasma concentration.

10. Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

11. Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

12. Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

13. Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

14. Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

15. Maximum Observed Plasma Concentration (Cmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

16. Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

17. Maximum Observed Plasma Concentration (Cmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

18. Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

19. Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Cmax is defined as maximum observed plasma concentration.

20. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.]

    AUClast is defined as area under the curve from time zero to last quantifiable concentration.

21. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

22. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 2 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

23. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

24. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

25. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

26. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    AUClast is defined as area under the curve from time zero to last quantifiable concentration.

27. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Docetaxel in Combination With PF-05212384 - Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    AUClast is defined as area under the curve from time zero to last quantifiable concentration.

28. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    AUClast is defined as area under the curve from time zero to last quantifiable concentration.

29. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    AUClast is defined as area under the curve from time zero to last quantifiable concentration.

30. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

31. Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    AUCtau is defined as area under the concentration-time profile from time 0 to time tau.

32. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.]

    Tmax is defined as time to reach maximum observed plasma concentration.

33. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

34. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

35. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

36. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

37. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A) [Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

38. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

39. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B) [Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

40. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

41. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C) [Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

42. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

43. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion) [Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.]

    Tmax is defined as time to reach maximum observed plasma concentration.

44. Mean Serum Biomarkers for Glucose - Baseline [Baseline]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This study employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.

45. Mean Serum Biomarkers for Glucose - End of Treatment [End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.

46. Mean Serum Biomarkers for Insulin - Baseline [Baseline]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.

47. Mean Serum Biomarkers for Insulin - End of Treatment [End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.

48. Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline [Baseline]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.

49. Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment [End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.]

    A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.

50. Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

51. Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

52. Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

53. Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation category was BRAF mutation status. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

54. Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

55. Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

56. Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

57. Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C [Baseline]

    Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.

58. Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval [Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).]

    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.

59. Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria [Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).]

    QT interval corrected using Fridericia's formula (QTcF) and Bazette's formula (QTcB): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to 480 msec, 480 msec to 500 msec, and more than (>) 500 msec.

60. Percentage of Participants With Objective Response - Arm A [Baseline up to 18 months.]

    Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

61. Percentage of Participants With Objective Response - Arm B [Baseline up to 18 months.]

    Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

62. Percentage of Participants With Objective Response - Arm C [Baseline up to 18 months.]

    Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

63. Clinical Benefit Response Rate - Arm B Expansion [Baseline up to 18 months.]

    Percent of participants with confirmed complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. SD was defined as not qualifying for CR, PR, Progressive Disease (PD).

64. Duration of Response - Arm B Expansion [Baseline up to 18 months.]

    Duration of response was calculated from first date of partial response (PR) or complete response (CR) to the date of progression or death due to any cause. In the event of no progression or death, the last tumor assessment date without progression was used in this calculation.

65. Progression Free Survival - Arm B Expansion [Baseline up to 18 months.]

    Progression free survival (PFS) defined as the time from first dose of study treatment to date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as first event date minus the date of first dose of study medication plus 1 . Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

66. Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion [Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.]

    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

67. Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion [Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.]

    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Cisplatin Combination Expansion:

Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.

• Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.

• Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.

• Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.

• Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.

• Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.

• Adequate bone marrow, renal and liver function.

Exclusion Criteria:

• Prior therapy for Cisplatin Combination Expansion:

• Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;

• Prior radiation to >25% bone marrow as estimated by the Investigator.

• Patients with known symptomatic brain metastases.

• Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.

• Major surgery within 4 weeks of the baseline disease assessments.

• 2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.

• Active bacterial, fungal or viral infection.

• Uncontrolled or significant cardiovascular disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
3	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
4	UCLA Hematology Oncology	Los Angeles	California	United States	90095
5	Westwood Bowyer Clinic	Los Angeles	California	United States	90095
6	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
7	Santa Monica UCLA Medical Center & Orthopaedic Hospital	Santa Monica	California	United States	90404
8	UCLA Hematology Oncology	Santa Monica	California	United States	90404
9	University of Colorado Denver CTO (CTRC)	Aurora	Colorado	United States	80045
10	University of Colorado Hospital	Aurora	Colorado	United States	80045
11	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
12	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
13	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
14	Harper Professional Building	Detroit	Michigan	United States	48201
15	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
16	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
17	Medical University of South Carolina/ University Hospital	Charleston	South Carolina	United States	29425
18	Medical University of South Carolina	Charleston	South Carolina	United States	29425
19	MUSC SCTR Research	Charleston	South Carolina	United States	29425
20	MUSC Health East Cooper	Mount Pleasant	South Carolina	United States	29464
21	MUSC Specialty Care-North	North Charleston	South Carolina	United States	29406
22	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia	Canada	V5Z 4E6
23	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
24	Istituto Europeo di Oncologia - Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative	Milano	MI	Italy	20141
25	Istituto Regina Elena Struttura Complessa Oncologia Medica A	Roma	RM	Italy	00144
26	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
27	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
28	University College London Hospital, NIHR UCLH Clinical Research Facility	London		United Kingdom	W1T 7HA
29	Oxford Cancer Centre	Oxford		United Kingdom	OX3 7LE

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Nov 11, 2016
• Statistical Analysis Plan - Nov 27, 2017

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01920061
• Other Study ID Numbers: B2151002; 2013-001390-24
• First Posted: Aug 9, 2013
• Last Update Posted: Oct 7, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Advanced cancer; solid tumors; PI3K; mTOR; PI3K/mTOR; metastatic; Triple Negative Breast Cancer (TNBC)
• Additional relevant MeSH terms: Triple Negative Breast Neoplasms; Docetaxel; Gedatolisib

Study Results

Participant Flow

Recruitment Details	Arm A included 5 sub-arms: Arms A1, A2, A3, A4, A5 Arm B included 8 sub-arms: Arms B1, B2, B3, B4, B5, B6, B7, B8 Arm C included 5 sub-arms: Arms C1, C1h, C2, C3, C4 Arm B Expansion included 2 sub-arms: Arms 1, 2
Pre-assignment Detail	A total of 110 subjets were enrolled in this study and 3 of them didn't received any study treatment.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastatic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Period Title: Overall Study
STARTED	4	5	3	4	5	4	3	3	3	3	10	5	3	16	4	7	3	3	10	12
Received Treatment	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
COMPLETED	2	1	1	2	3	2	2	2	2	1	5	2	1	10	3	4	1	1	4	8
NOT COMPLETED	2	4	2	2	2	2	1	1	1	2	5	3	2	6	1	3	2	2	6	4

Baseline Characteristics

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastatic	Arm 2: 2L/3L Metastatic	Total
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Total of all reporting groups
Overall Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (4.7)	62.0 (10.9)	61.7 (7.6)	58.3 (15.9)	63.6 (8.1)	57.3 (9.1)	51.7 (13.6)	54.7 (15.9)	54.0 (9.6)	55.7 (8.5)	54.6 (11.1)	58.2 (13.7)	59.5 (13.4)	53.4 (14.1)	54.3 (22.1)	55.4 (8.8)	49.7 (6.4)	56.3 (12.4)	52.4 (13.6)	54.8 (11.6)	55.5 (10.7)
Sex: Female, Male (Count of Participants)
Female	2 50%	3 60%	1 33.3%	2 66.7%	2 40%	2 50%	2 66.7%	2 66.7%	2 66.7%	3 100%	10 100%	3 60%	2 100%	8 53.3%	4 100%	0 0%	2 66.7%	1 33.3%	10 100%	12 100%	73 68.2%
Male	2 50%	2 40%	2 66.7%	1 33.3%	3 60%	2 50%	1 33.3%	1 33.3%	1 33.3%	0 0%	0 0%	2 40%	0 0%	7 46.7%	0 0%	7 100%	1 33.3%	2 66.7%	0 0%	0 0%	34 31.8%
Race/Ethnicity, Customized (Count of Participants)
White	4 100%	5 100%	3 100%	3 100%	3 60%	4 100%	3 100%	2 66.7%	3 100%	3 100%	9 90%	4 80%	2 100%	14 93.3%	3 75%	7 100%	2 66.7%	3 100%	9 90%	11 91.7%	97 90.7%
Black	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	1 33.3%	0 0%	1 10%	0 0%	5 4.7%
Asian	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	1 20%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	5 4.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C
Description	DLT was defined as any of the following adverse events (AEs) attributable to the combination: (1) hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia; grade >=3 neutropenia with infection; grade 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=2 pneumonitis; grade>=3 toxicities, except pneumonitis, and excluding those that had not been maximally treated; persistent, intolerable toxicities which resulted in the failure to deliver at least 3 of the 4 doses of PF-05212384 for Arms A and B or at least 3 of the 4 doses of PF-05212384 and 75% of dacomitinib for Arm C during the first cycle; the persistent, intolerable toxicities which result in delay of the start of the second cycle by more than 2 weeks relative to the scheduled start; in an asymptomatic participant, the grade 3 QTc prolongation persists after correction of any reversible causes.
Time Frame	Up to 21 days

Outcome Measure Data

Analysis Population Description

The per protocol analysis set included all enrolled participants who received at least one dose of study medication and who did not receive less than 75% or more than 125% of the planned Cycle 1 dose of either study drug in the combination.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	4	3	3	3	2	3	3	3	3	3	8	3	2	13	2	7	3	2
With DLT	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 100%	0 0%	2 50%	2 28.6%	0 0%	0 0%
No DLT	4 100%	3 60%	2 66.7%	3 100%	1 20%	3 75%	3 100%	3 100%	3 100%	3 100%	8 80%	3 60%	0 0%	13 86.7%	0 0%	5 71.4%	3 100%	2 66.7%
Data missing	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Percentage of Participants With Objective Response - Arm B Expansion
Description	Percentage of participants with objective response based on the assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Time Frame	Cycle 1 Day 1 up to 18 months

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	12
Number (95% Confidence Interval) [Percentage of participants]	40.0 1000%	33.3 666%

3. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Description	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Grade 1 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	1 33.3%	0 0%	2 40%	0 0%	5 33.3%	0 0%	3 42.9%	3 100%	1 33.3%	1 10%	3 25%
Grade 3 AEs	2 50%	2 40%	2 66.7%	0 0%	0 0%	2 50%	2 66.7%	2 66.7%	1 33.3%	1 33.3%	9 90%	2 40%	2 100%	6 40%	4 100%	4 57.1%	0 0%	2 66.7%	8 80%	7 58.3%
Grade 4 AEs	2 50%	2 40%	1 33.3%	2 66.7%	5 100%	0 0%	1 33.3%	0 0%	2 66.7%	0 0%	1 10%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%
Grade 5 AEs	0 0%	1 20%	0 0%	1 33.3%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 33.3%	0 0%	1 20%	0 0%	2 13.3%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%

4. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Description	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Grade 1 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 26.7%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	2 50%	1 33.3%	1 33.3%	0 0%	1 33.3%	0 0%	2 40%	0 0%	6 40%	1 25%	4 57.1%	3 100%	1 33.3%	4 40%	4 33.3%
Grade 3 AEs	2 50%	3 60%	2 66.7%	1 33.3%	0 0%	1 25%	1 33.3%	2 66.7%	2 66.7%	2 66.7%	9 90%	3 60%	2 100%	4 26.7%	2 50%	3 42.9%	0 0%	2 66.7%	6 60%	6 50%
Grade 4 AEs	2 50%	2 40%	1 33.3%	2 66.7%	5 100%	0 0%	1 33.3%	0 0%	1 33.3%	0 0%	1 10%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%
Grade 5 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Description	Laboratory abnormalities were graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: anemia,hemoglobin increased, platelets, white blood cells, absolute neutrophils,lymphocyte count increased, lymphopenia.
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Grade 0	0 0%	1 20%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	4 26.7%	1 25%	2 28.6%	2 66.7%	0 0%	0 0%	0 0%
Grade 1	2 50%	2 40%	1 33.3%	0 0%	3 60%	0 0%	1 33.3%	2 66.7%	1 33.3%	1 33.3%	2 20%	1 20%	1 50%	6 40%	2 50%	5 71.4%	0 0%	1 33.3%	1 10%	0 0%
Grade 2	2 50%	1 20%	2 66.7%	3 100%	2 40%	3 75%	2 66.7%	1 33.3%	2 66.7%	2 66.7%	6 60%	2 40%	1 50%	5 33.3%	1 25%	0 0%	1 33.3%	2 66.7%	6 60%	8 66.7%
Grade 3	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 20%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	3 30%	4 33.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	5 100%	3 100%	3 100%	5 100%	4 100%	3 100%	3 100%	3 100%	3 100%	10 100%	5 100%	2 100%	15 100%	4 100%	7 100%	3 100%	3 100%	9 90%	12 100%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	5 100%	3 100%	3 100%	5 100%	4 100%	3 100%	3 100%	3 100%	3 100%	9 90%	5 100%	2 100%	15 100%	4 100%	7 100%	3 100%	3 100%	10 100%	12 100%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	1 33.3%	1 33.3%	1 33.3%	0 0%	2 20%	2 40%	0 0%	1 6.7%	0 0%	1 14.3%	0 0%	1 33.3%	2 20%	2 16.7%
Grade 1	1 25%	2 40%	0 0%	1 33.3%	1 20%	2 50%	1 33.3%	0 0%	1 33.3%	1 33.3%	3 30%	1 20%	1 50%	7 46.7%	2 50%	2 28.6%	2 66.7%	0 0%	3 30%	3 25%
Grade 2	2 50%	1 20%	1 33.3%	1 33.3%	4 80%	2 50%	0 0%	1 33.3%	0 0%	1 33.3%	4 40%	1 20%	0 0%	6 40%	2 50%	4 57.1%	1 33.3%	1 33.3%	3 30%	4 33.3%
Grade 3	1 25%	1 20%	2 66.7%	1 33.3%	0 0%	0 0%	1 33.3%	1 33.3%	1 33.3%	1 33.3%	1 10%	1 20%	1 50%	1 6.7%	0 0%	0 0%	0 0%	1 33.3%	2 20%	3 25%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	1 20%	1 33.3%	0 0%	0 0%	3 75%	2 66.7%	2 66.7%	2 66.7%	1 33.3%	2 20%	3 60%	1 50%	14 93.3%	4 100%	7 100%	2 66.7%	3 100%	3 30%	5 41.7%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	1 33.3%	0 0%	1 33.3%	2 20%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	1 33.3%	3 30%	2 40%	1 50%	1 6.7%	0 0%	0 0%	0 0%	0 0%	3 30%	3 25%
Grade 3	2 50%	1 20%	1 33.3%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 40%	4 33.3%
Grade 4	2 50%	3 60%	1 33.3%	2 66.7%	5 100%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	5 100%	2 66.7%	3 100%	5 100%	2 50%	1 33.3%	1 33.3%	2 66.7%	0 0%	6 60%	3 60%	1 50%	15 100%	4 100%	6 85.7%	3 100%	3 100%	7 70%	7 58.3%
Grade 1	3 75%	0 0%	0 0%	0 0%	0 0%	2 50%	1 33.3%	2 66.7%	1 33.3%	1 33.3%	4 40%	1 20%	1 50%	0 0%	0 0%	1 14.3%	0 0%	0 0%	2 20%	3 25%
Grade 2	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 0	0 0%	1 20%	1 33.3%	0 0%	0 0%	1 25%	1 33.3%	3 100%	2 66.7%	0 0%	2 20%	2 40%	1 50%	10 66.7%	3 75%	6 85.7%	1 33.3%	3 100%	1 10%	1 8.3%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	2 50%	1 33.3%	0 0%	0 0%	1 33.3%	2 20%	3 60%	1 50%	5 33.3%	1 25%	1 14.3%	2 66.7%	0 0%	3 30%	5 41.7%
Grade 2	1 25%	1 20%	0 0%	1 33.3%	0 0%	1 25%	1 33.3%	0 0%	0 0%	2 66.7%	5 50%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 40%	5 41.7%
Grade 3	2 50%	2 40%	1 33.3%	0 0%	4 80%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 20%	1 8.3%
Grade 4	1 25%	1 20%	1 33.3%	2 66.7%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Description	Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: partial thromboplastin time and prothrombin time international normalized ratio(INR).
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Grade 0	4 100%	4 80%	3 100%	2 66.7%	5 100%	2 50%	3 100%	3 100%	2 66.7%	2 66.7%	9 90%	5 100%	2 100%	7 46.7%	2 50%	4 57.1%	1 33.3%	2 66.7%	9 90%	10 83.3%
Grade 1	0 0%	1 20%	0 0%	1 33.3%	0 0%	2 50%	0 0%	0 0%	1 33.3%	1 33.3%	1 10%	0 0%	0 0%	6 40%	1 25%	2 28.6%	1 33.3%	1 33.3%	1 10%	1 8.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	1 25%	1 14.3%	0 0%	0 0%	0 0%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	4 80%	2 66.7%	3 100%	4 80%	3 75%	3 100%	3 100%	2 66.7%	3 100%	9 90%	5 100%	2 100%	13 86.7%	4 100%	6 85.7%	3 100%	3 100%	8 80%	10 83.3%
Grade 1	3 75%	1 20%	1 33.3%	0 0%	1 20%	1 25%	0 0%	0 0%	1 33.3%	0 0%	1 10%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	2 20%	2 16.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Description	Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), total bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia.
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Grade 0	3 75%	4 80%	2 66.7%	2 66.7%	5 100%	3 75%	2 66.7%	2 66.7%	1 33.3%	2 66.7%	5 50%	1 20%	0 0%	10 66.7%	3 75%	6 85.7%	3 100%	3 100%	7 70%	7 58.3%
Grade 1	1 25%	1 20%	1 33.3%	0 0%	0 0%	1 25%	1 33.3%	1 33.3%	0 0%	1 33.3%	4 40%	4 80%	2 100%	5 33.3%	1 25%	1 14.3%	0 0%	0 0%	2 20%	5 41.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 66.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	3 75%	4 80%	2 66.7%	2 66.7%	4 80%	2 50%	2 66.7%	1 33.3%	1 33.3%	1 33.3%	8 80%	3 60%	1 50%	9 60%	2 50%	7 100%	3 100%	1 33.3%	10 100%	8 66.7%
Grade 1	1 25%	1 20%	0 0%	1 33.3%	0 0%	1 25%	1 33.3%	2 66.7%	2 66.7%	1 33.3%	1 10%	2 40%	1 50%	5 33.3%	1 25%	0 0%	0 0%	2 66.7%	0 0%	3 25%
Grade 2	0 0%	0 0%	1 33.3%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	1 33.3%	1 10%	0 0%	0 0%	1 6.7%	1 25%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	3 75%	2 40%	2 66.7%	2 66.7%	4 80%	3 75%	1 33.3%	2 66.7%	1 33.3%	1 33.3%	9 90%	3 60%	1 50%	12 80%	3 75%	5 71.4%	3 100%	2 66.7%	5 50%	6 50%
Grade 1	1 25%	3 60%	1 33.3%	0 0%	0 0%	1 25%	2 66.7%	1 33.3%	1 33.3%	1 33.3%	0 0%	2 40%	1 50%	3 20%	1 25%	2 28.6%	0 0%	1 33.3%	5 50%	5 41.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	3 75%	4 80%	3 100%	3 100%	5 100%	4 100%	3 100%	3 100%	3 100%	3 100%	9 90%	5 100%	2 100%	13 86.7%	4 100%	5 71.4%	3 100%	3 100%	10 100%	12 100%
Grade 1	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 13.3%	0 0%	2 28.6%	0 0%	0 0%	0 0%	0 0%
Grade 2	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	0 0%	1 33.3%	1 33.3%	1 20%	1 25%	0 0%	0 0%	1 33.3%	0 0%	1 10%	1 20%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	2 16.7%
Grade 1	4 100%	5 100%	2 66.7%	1 33.3%	4 80%	2 50%	2 66.7%	3 100%	1 33.3%	3 100%	6 60%	3 60%	1 50%	12 80%	3 75%	7 100%	3 100%	3 100%	6 60%	4 33.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	1 33.3%	0 0%	1 33.3%	0 0%	3 30%	1 20%	1 50%	3 20%	0 0%	0 0%	0 0%	0 0%	4 40%	5 41.7%
Grade 3	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	4 80%	2 66.7%	2 66.7%	5 100%	4 100%	3 100%	3 100%	2 66.7%	3 100%	8 80%	5 100%	2 100%	13 86.7%	3 75%	7 100%	3 100%	3 100%	8 80%	10 83.3%
Grade 1	0 0%	1 20%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 10%	0 0%	0 0%	2 13.3%	1 25%	0 0%	0 0%	0 0%	2 20%	2 16.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	1 20%	0 0%	1 33.3%	0 0%	1 25%	0 0%	0 0%	1 33.3%	2 66.7%	2 20%	0 0%	0 0%	6 40%	1 25%	4 57.1%	1 33.3%	2 66.7%	4 40%	2 16.7%
Grade 1	2 50%	4 80%	1 33.3%	1 33.3%	3 60%	3 75%	2 66.7%	1 33.3%	0 0%	1 33.3%	5 50%	3 60%	2 100%	8 53.3%	2 50%	3 42.9%	2 66.7%	0 0%	4 40%	7 58.3%
Grade 2	1 25%	0 0%	2 66.7%	1 33.3%	2 40%	0 0%	0 0%	1 33.3%	2 66.7%	0 0%	2 20%	2 40%	0 0%	0 0%	1 25%	0 0%	0 0%	1 33.3%	1 10%	3 25%
Grade 3	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	1 33.3%	0 0%	0 0%	1 10%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	4 80%	2 66.7%	1 33.3%	5 100%	4 100%	3 100%	3 100%	3 100%	3 100%	10 100%	5 100%	2 100%	13 86.7%	4 100%	7 100%	3 100%	2 66.7%	9 90%	11 91.7%
Grade 1	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	1 33.3%	1 10%	0 0%
Grade 2	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	1 20%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	5 100%	2 66.7%	2 66.7%	4 80%	4 100%	3 100%	3 100%	3 100%	3 100%	10 100%	5 100%	2 100%	15 100%	4 100%	6 85.7%	3 100%	3 100%	10 100%	11 91.7%
Grade 1	0 0%	0 0%	1 33.3%	1 33.3%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%	1 8.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	4 80%	3 100%	3 100%	5 100%	4 100%	3 100%	3 100%	3 100%	3 100%	10 100%	5 100%	2 100%	15 100%	4 100%	7 100%	3 100%	3 100%	10 100%	12 100%
Grade 1	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	4 80%	2 66.7%	1 33.3%	3 60%	3 75%	2 66.7%	3 100%	1 33.3%	1 33.3%	6 60%	2 40%	0 0%	9 60%	2 50%	6 85.7%	2 66.7%	2 66.7%	5 50%	10 83.3%
Grade 1	2 50%	1 20%	1 33.3%	1 33.3%	2 40%	1 25%	1 33.3%	0 0%	1 33.3%	1 33.3%	3 30%	1 20%	2 100%	4 26.7%	2 50%	1 14.3%	1 33.3%	1 33.3%	5 50%	0 0%
Grade 2	1 25%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	1 33.3%	1 33.3%	1 10%	2 40%	0 0%	2 13.3%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	4 80%	2 66.7%	2 66.7%	4 80%	4 100%	0 0%	3 100%	2 66.7%	2 66.7%	8 80%	3 60%	1 50%	10 66.7%	3 75%	6 85.7%	2 66.7%	2 66.7%	9 90%	5 41.7%
Grade 1	2 50%	1 20%	1 33.3%	0 0%	1 20%	0 0%	2 66.7%	0 0%	0 0%	0 0%	1 10%	2 40%	0 0%	5 33.3%	1 25%	1 14.3%	1 33.3%	1 33.3%	0 0%	6 50%
Grade 2	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	1 33.3%	0 0%	1 33.3%	1 33.3%	1 10%	0 0%	1 50%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	4 100%	5 100%	3 100%	3 100%	5 100%	3 75%	3 100%	3 100%	2 66.7%	3 100%	9 90%	5 100%	2 100%	15 100%	4 100%	7 100%	3 100%	3 100%	10 100%	12 100%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	3 75%	5 100%	2 66.7%	2 66.7%	5 100%	4 100%	1 33.3%	2 66.7%	2 66.7%	2 66.7%	3 30%	4 80%	1 50%	11 73.3%	2 50%	6 85.7%	2 66.7%	3 100%	10 100%	7 58.3%
Grade 1	1 25%	0 0%	1 33.3%	1 33.3%	0 0%	0 0%	2 66.7%	1 33.3%	1 33.3%	0 0%	5 50%	1 20%	0 0%	3 20%	0 0%	1 14.3%	1 33.3%	0 0%	0 0%	2 16.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	2 20%	0 0%	1 50%	1 6.7%	2 50%	0 0%	0 0%	0 0%	0 0%	3 25%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 50%	5 100%	3 100%	3 100%	5 100%	2 50%	1 33.3%	0 0%	1 33.3%	3 100%	4 40%	2 40%	1 50%	6 40%	0 0%	5 71.4%	2 66.7%	2 66.7%	5 50%	4 33.3%
Grade 1	2 50%	0 0%	0 0%	0 0%	0 0%	2 50%	0 0%	2 66.7%	1 33.3%	0 0%	3 30%	2 40%	1 50%	9 60%	4 100%	2 28.6%	1 33.3%	1 33.3%	4 40%	5 41.7%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 66.7%	1 33.3%	1 33.3%	0 0%	1 10%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	1 8.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	3 60%	2 66.7%	0 0%	2 40%	1 25%	2 66.7%	1 33.3%	2 66.7%	1 33.3%	5 50%	1 20%	0 0%	6 40%	3 75%	4 57.1%	2 66.7%	1 33.3%	6 60%	5 41.7%
Grade 1	3 75%	1 20%	0 0%	2 66.7%	3 60%	3 75%	1 33.3%	2 66.7%	1 33.3%	2 66.7%	4 40%	2 40%	2 100%	6 40%	1 25%	2 28.6%	1 33.3%	2 66.7%	4 40%	6 50%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	1 20%	1 33.3%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	2 40%	0 0%	3 20%	0 0%	1 14.3%	0 0%	0 0%	0 0%	1 8.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 25%	4 80%	1 33.3%	0 0%	4 80%	3 75%	1 33.3%	1 33.3%	1 33.3%	2 66.7%	9 90%	4 80%	1 50%	14 93.3%	2 50%	5 71.4%	3 100%	2 66.7%	8 80%	8 66.7%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	1 10%	0 0%
Grade 2	3 75%	1 20%	2 66.7%	2 66.7%	1 20%	1 25%	2 66.7%	1 33.3%	1 33.3%	0 0%	1 10%	1 20%	1 50%	0 0%	1 25%	1 14.3%	0 0%	1 33.3%	0 0%	4 33.3%
Grade 3	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 33.3%	0 0%	0 0%	0 0%	1 6.7%	1 25%	0 0%	0 0%	0 0%	1 10%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Description	Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameter was analyzed for laboratory examination: urine protein.
Time Frame	From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least one dose of study medication.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	2	10	12
Grade 0	1 25%	2 40%	1 33.3%	1 33.3%	2 40%	3 75%	1 33.3%	2 66.7%	0 0%	1 33.3%	8 80%	5 100%	0 0%	6 40%	4 100%	3 42.9%	3 100%	1 33.3%	8 80%	5 41.7%
Grade 1	3 75%	3 60%	2 66.7%	2 66.7%	2 40%	1 25%	2 66.7%	1 33.3%	3 100%	1 33.3%	2 20%	0 0%	2 100%	6 40%	0 0%	2 28.6%	0 0%	0 0%	2 20%	7 58.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	3 20%	0 0%	2 28.6%	0 0%	1 33.3%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Description	Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position.
Time Frame	From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment). Maximum duration between first and last dose: 842 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3	10	12
Sitting SBP<=100 mmHg	1 25%	2 40%	0 0%	3 100%	1 20%	0 0%	1 33.3%	0 0%	2 66.7%	0 0%	3 30%	2 40%	1 50%	4 26.7%	1 25%	2 28.6%	2 66.7%	0 0%	6 60%	6 50%
Sitting SBP>=160 mmHg	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	1 25%	0 0%	0 0%	0 0%	1 10%	2 16.7%
Sitting DBP<=60 mmHg	1 25%	2 40%	0 0%	2 66.7%	2 40%	2 50%	2 66.7%	2 66.7%	2 66.7%	0 0%	2 20%	2 40%	0 0%	5 33.3%	2 50%	2 28.6%	1 33.3%	0 0%	7 70%	6 50%
Sitting DBP>=100 mmHg	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 13.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sitting heart rate<50 bpm	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sitting heart rate>120 bpm	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 25%	0 0%	0 0%	2 66.7%	1 33.3%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Max increase from baseline in sitting SBP>=20 mmHg	2 50%	0 0%	2 66.7%	1 33.3%	2 40%	0 0%	1 33.3%	1 33.3%	1 33.3%	1 33.3%	4 40%	1 20%	2 100%	3 20%	1 25%	4 57.1%	1 33.3%	0 0%	4 40%	4 33.3%
Max increase from baseline in sitting SBP>=40 mmHg	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	1 14.3%	0 0%	0 0%	3 30%	1 8.3%
Max increase from baseline in sitting SBP>=60 mmHg	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Max increase from baseline in sitting DBP>=10 mmHg	1 25%	1 20%	2 66.7%	1 33.3%	2 40%	0 0%	2 66.7%	2 66.7%	1 33.3%	2 66.7%	8 80%	2 40%	1 50%	4 26.7%	1 25%	3 42.9%	1 33.3%	0 0%	6 60%	5 41.7%
Max increase from baseline in sitting DBP>=20 mmHg	0 0%	0 0%	0 0%	1 33.3%	1 20%	0 0%	1 33.3%	1 33.3%	1 33.3%	0 0%	3 30%	0 0%	1 50%	0 0%	0 0%	2 28.6%	0 0%	0 0%	1 10%	3 25%
Max increase from baseline in sitting DBP>=30 mmHg	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	6455 (30)	9539 (24)	12090 (21)	7128 (154)	12420 (27)	4522 (76)	7297 (6)	7969 (39)	9548 (20)	13350 (54)	15170 (63)	11510 (61)	NA (NA)	6703 (57)	8999 (49)	6783 (24)	4266 (80)	8261 (12)

11. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	12
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	11340 (60)	10690 (44)

12. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	4	3	3	4
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	8032 (36)	8095 (33)	10380 (26)	11110 (53)	10860 (33)

13. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	3	3	2	10	4	2
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	10670 (114)	7830 (104)	6273 (102)	9619 (57)	NA (NA)	18730 (24)	15000 (19)	NA (NA)

14. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	1	6	3	2
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	6739 (50)	NA (NA)	6328 (31)	8547 (48)	NA (NA)

15. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	11
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	9027 (52)	14670 (32)

16. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	5	3	3	5
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	946.7 (116)	2451 (23)	2528 (19)	1529 (93)	1058 (161)

17. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	4	3	3	4
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	1840 (95)	695.9 (253)	2457 (18)	1424 (126)	1300 (238)

18. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	4	3	3	3	3	10	5	2
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	3397 (29)	3950 (1)	3014 (10)	4041 (14)	3337 (8)	3474 (31)	3293 (18)	NA (NA)

19. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	3	3	3	10	4	2
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	3867 (16)	4201 (7)	3205 (17)	4086 (10)	3130 (17)	3665 (23)	3211 (19)	NA (NA)

20. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	14	3	7	3
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	41.04 (33)	76.24 (45)	34.17 (61)	49.90 (38)

21. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
Description	Cmax is defined as maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	12	2	7	3
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	52.38 (36)	NA (NA)	33.64 (94)	48.10 (72)

22. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
Description	AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	2	4	3	2	4	3	3	1	3	3	8	4	2	14	4	7	3	3
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	NA (NA)	12530 (26)	15270 (21)	NA (NA)	18710 (28)	6756 (65)	8937 (21)	NA (NA)	14370 (16)	17710 (14)	24540 (35)	24480 (30)	NA (NA)	9191 (32)	13360 (35)	10050 (26)	9493 (32)	10370 (23)

23. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who have sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	4	3	3	4
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	10420 (44)	15110 (22)	15520 (26)	14540 (56)	15890 (27)

24. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	1	3	1	10	3	2
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	14620 (75)	12690 (58)	NA (NA)	18920 (77)	NA (NA)	38850 (71)	27480 (46)	NA (NA)

25. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	1	6	3	2
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	10870 (36)	NA (NA)	9977 (22)	15910 (45)	NA (NA)

26. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	9	12
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	20180 (42)	24480 (22)

27. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	7	9
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	25250 (49)	31160 (27)

28. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
Description	AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	3	5	3	3	5
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	1418 (88)	2748 (27)	2111 (11)	1594 (64)	1280 (63)

29. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Docetaxel in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
Description	AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	3	2	3	4
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	2921 (60)	2175 (26)	NA (NA)	1415 (115)	1383 (136)

30. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
Description	AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	4	3	3	3	3	10	5	2
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	50210 (7)	50860 (6)	44240 (8)	48870 (18)	42910 (23)	46560 (13)	48350 (24)	NA (NA)

31. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
Description	AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	2	3	3	9	4	2
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	59390 (7)	62990 (11)	NA (NA)	56170 (22)	52940 (10)	53470 (11)	47500 (18)	NA (NA)

32. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	3	7	3
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	818.8 (34)	1604 (36)	697.0 (62)	1040 (34)

33. Secondary Outcome

Title	Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
Description	AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	12	2	7	2
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	1069 (38)	NA (NA)	703.8 (100)	NA (NA)

34. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	4	5	3	3	5	4	3	3	3	3	10	5	2	15	4	7	3	3
Median (Full Range) [hr]	0.500	0.500	0.500	0.550	0.500	0.584	0.517	0.500	0.500	0.533	0.509	0.500	NA	0.500	0.500	0.533	0.500	0.533

35. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	4	3	3	4
Median (Full Range) [hr]	0.517	0.500	0.500	0.517	0.542

36. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	3	3	2	10	4	2
Median (Full Range) [hr]	0.500	0.500	0.550	0.500	0.675	0.517	0.517	NA

37. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	1	6	3	2
Median (Full Range) [hr]	0.500	NA	0.500	0.500	NA

38. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	5	3	3	5
Median (Full Range) [hr]	1.12	1.00	1.00	1.02	1.05

39. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	4	3	3	4
Median (Full Range) [hr]	1.06	1.34	1.03	1.02	1.13

40. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	4	3	3	3	3	10	5	2
Median (Full Range) [hr]	2.08	2.12	2.10	2.00	2.05	2.01	2.00	NA

41. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	3	3	3	3	3	10	4	2
Median (Full Range) [hr]	2.05	2.00	2.00	2.00	2.00	2.02	2.01	NA

42. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	14	3	7	3
Median (Full Range) [hr]	4.08	6.00	6.00	5.97

43. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	12	2	7	3
Median (Full Range) [hr]	6.04	NA	6.00	5.42

44. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	12
Median (Full Range) [hr]	0.517	0.600

45. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
Description	Tmax is defined as time to reach maximum observed plasma concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	11
Median (Full Range) [hr]	0.517	0.500

46. Secondary Outcome

Title	Mean Serum Biomarkers for Glucose - Baseline
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This study employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	19	32	31
In population of BC	106.80 (18.820)	95.07 (12.019)
In population of NSCLC	99.56 (15.316)	100.97 (9.154)	97.00 (10.10)
In population of prostate cancer	124.51 (20.624)
In population of OC	102.71 (15.29)
In population of TCC	109.70 (18.335)
In population of TNBC	95.66 (10.659)
In population of head and neck cancer	90.68 (14.422)
In population of oesophageal carcinoma	103.54 (14.970)

47. Secondary Outcome

Title	Mean Serum Biomarkers for Glucose - End of Treatment
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	15	29	29
In population of BC	120.00 (37.242)	99.84 (12.820)
In population of NSCLC	96.13 (10.500)	108.11 (10.698)	97.50 (17.046)
In population of prostate cancer	136.91 (59.555)
In population of OC	143.26 (34.404)
In population of TCC	100.71 (24.112)
In population of TNBC	108.29 (36.210)
In population of head and neck cancer	90.19 (15.367)
In population of oesophageal carcinoma	1.14 (0.210)

48. Secondary Outcome

Title	Mean Serum Biomarkers for Insulin - Baseline
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	15	27	23
In population of BC	10.93 (3.942)	155.14 (212.916)
In population of NSCLC	28.61 (56.678)	710.50 (1346.142)	11.53 (4.279)
In population of prostate cancer	12.65 (13.268)
In population of OC	12.50 (1.980)
In population of TCC	20.68 (3.446)
In population of TNBC	81.16 (204.586)
In population of head and neck cancer	101.31 (187.285)
In population of oesophageal carcinoma	338.98 (441.323)

49. Secondary Outcome

Title	Mean Serum Biomarkers for Insulin - End of Treatment
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	15	27	23
In population of BC	19.17 (8.578)	318.62 (365.374)
In population of NSCLC	22.34 (20.913)	832.87 (806.616)	18.26 (10.559)
In population of prostate cancer	13.73 (17.017)
In population of OC	80.30 (81.459)
In population of TCC	41.65 (8.505)
In population of TNBC	56.69 (120.565)
In population of head and neck cancer	289.32 (606.589)
In population of oesophageal carcinoma	436.94 (612.108)

50. Secondary Outcome

Title	Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	26	18
In population of BC	7.92 (0.115)	7.00 (1.742)
In population of NSCLC	7.27 (1.074)	6.65 (0.931)	5.13 (0.065)
In population of prostate cancer	8.03 (0.465)
In population of OC	7.70 (0.354)
In population of TCC	7.65 (0.696)
In population of TNBC	7.18 (1.195)
In population of head and neck cancer	7.50 (1.107)
In population of oesophageal carcinoma	7.00 (1.065)

51. Secondary Outcome

Title	Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
Description	A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Time Frame	End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.

Outcome Measure Data

Analysis Population Description

The serum pharmacodynamics analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	13	26	18
In population of BC	NA (NA)	8.39 (1.050)
In population of NSCLC	7.70 (1.087)	6.74 (1.572)	NA (NA)
In population of prostate cancer	8.42 (1.332)
In population of OC	25.10 (22.698)
In population of TCC	7.72 (0.551)
In population of TNBC	7.72 (1.408)
In population of head and neck cancer	7.72 (1.012)
In population of oesophageal carcinoma	7.61 (1.404)

52. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm A	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	3	5
BRAF - BRAF mutaion status (mutation detected)	0 0%	0 0%
BRAF - BRAF mutaion status (mutation not detected)	33.3 832.5%	40.0 800%
BRAF - V600E (mutation detected)	0 0%	0 0%
BRAF - V600E (mutation not detected)	66.7 1667.5%	40.0 800%
KRAS - GLY12ALA (mutation detected)	0 0%	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY12ARG (mutation detected)	0 0%	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY12ASP (mutation detected)	0 0%	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY12CYS (mutation detected)	0 0%	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY12SER (mutation detected)	0 0%	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY12VAL (mutation detected)	0 0%	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%	80.0 1600%
KRAS - GLY13ASP (mutation detected)	0 0%	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%	80.0 1600%

53. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm A	Arm B	Arm C
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	7	5	4
BRAF - BRAF mutaion status (mutation detected)	0 0%	0 0%	0 0%
BRAF - BRAF mutaion status (mutation not detected)	14.3 357.5%	80.0 1600%	25.0 833.3%
BRAF - V600E (mutation detected)	0 0%	0 0%	0 0%
BRAF - V600E (mutation not detected)	85.7 2142.5%	20.0 400%	75.0 2500%
KRAS - GLY12ALA (mutation detected)	0 0%	5 100%	0 0%
KRAS - GLY12ALA (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%
KRAS - GLY12ARG (mutation detected)	0 0%	0 0%	0 0%
KRAS - GLY12ARG (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%
KRAS - GLY12ASP (mutation detected)	14.3 357.5%	0 0%	0 0%
KRAS - GLY12ASP (mutation not detected)	71.4 1785%	100.0 2000%	100.0 3333.3%
KRAS - GLY12CYS (mutation detected)	0 0%	0 0%	0 0%
KRAS - GLY12CYS (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%
KRAS - GLY12SER (mutation detected)	0 0%	0 0%	0 0%
KRAS - GLY12SER (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%
KRAS - GLY12VAL (mutation detected)	0 0%	0 0%	0 0%
KRAS - GLY12VAL (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%
KRAS - GLY13ASP (mutation detected)	0 0%	0 0%	0 0%
KRAS - GLY13ASP (mutation not detected)	85.7 2142.5%	100.0 2000%	100.0 3333.3%

54. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm A
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90-180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	3
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	66.7 1667.5%
BRAF - V600E (mutation detected)	0 0%
BRAF - V600E (mutation not detected)	33.3 832.5%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%
KRAS - GLY12CYS (mutation detected)	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

55. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation category was BRAF mutation status. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm B
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	2
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	100.0 2500%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%
KRAS - GLY12CYS (mutation detected)	50.0 1250%
KRAS - GLY12CYS (mutation not detected)	50.0 1250%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

56. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm B
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	7
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	28.6 715%
BRAF - V600E (mutation detected)	0 0%
BRAF - V600E (mutation not detected)	71.4 1785%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%
KRAS - GLY12CYS (mutation detected)	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	14.3 357.5%
KRAS - GLY12VAL (mutation not detected)	85.7 2142.5%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

57. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm B
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90-310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	13
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	38.5 962.5%
BRAF - V600E (mutation detected)	0 0%
BRAF - V600E (mutation not detected)	38.5 962.5%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%
KRAS - GLY12CYS (mutation detected)	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

58. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm C
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	10
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	10.0 250%
BRAF - V600E (mutation detected)	0 0%
BRAF - V600E (mutation not detected)	90.0 2250%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	0 0%
KRAS - GLY12ASP (mutation not detected)	100.0 2500%
KRAS - GLY12CYS (mutation detected)	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

59. Secondary Outcome

Title	Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
Description	Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.

Arm/Group Title	Arm C
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90-150 mg once on Day -14 and dacomitinib 30-45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30-45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90-150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30-45 mg orally once followed by PF-05212384 90-150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	7
BRAF - BRAF mutaion status (mutation detected)	0 0%
BRAF - BRAF mutaion status (mutation not detected)	42.9 1072.5%
BRAF - V600E (mutation detected)	0 0%
BRAF - V600E (mutation not detected)	42.9 1072.5%
KRAS - GLY12ALA (mutation detected)	0 0%
KRAS - GLY12ALA (mutation not detected)	100.0 2500%
KRAS - GLY12ARG (mutation detected)	0 0%
KRAS - GLY12ARG (mutation not detected)	100.0 2500%
KRAS - GLY12ASP (mutation detected)	14.3 357.5%
KRAS - GLY12ASP (mutation not detected)	85.7 2142.5%
KRAS - GLY12CYS (mutation detected)	0 0%
KRAS - GLY12CYS (mutation not detected)	100.0 2500%
KRAS - GLY12SER (mutation detected)	0 0%
KRAS - GLY12SER (mutation not detected)	100.0 2500%
KRAS - GLY12VAL (mutation detected)	0 0%
KRAS - GLY12VAL (mutation not detected)	100.0 2500%
KRAS - GLY13ASP (mutation detected)	0 0%
KRAS - GLY13ASP (mutation not detected)	100.0 2500%

60. Secondary Outcome

Title	Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Description	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.
Time Frame	Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).

Outcome Measure Data

Analysis Population Description

The QTc analysis set was defined as all enrolled participants who had at least one ECG assessment after receiving study drug or study drugs.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	1	4	4	2	3	1	3	10	4	1	11	2	7	3	2	10	12
Change <= 30	4 100%	5 100%	3 100%	1 33.3%	4 80%	4 100%	2 66.7%	3 100%	1 33.3%	3 100%	10 100%	3 60%	1 50%	10 66.7%	2 50%	5 71.4%	3 100%	2 66.7%	9 90%	7 58.3%
30 < Change <= 60	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	1 6.7%	0 0%	1 14.3%	0 0%	0 0%	0 0%	4 33.3%
Change > 60	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	1 10%	1 8.3%
Change <= 30	4 100%	5 100%	3 100%	1 33.3%	4 80%	4 100%	2 66.7%	3 100%	1 33.3%	3 100%	10 100%	3 60%	1 50%	11 73.3%	2 50%	6 85.7%	3 100%	2 66.7%	9 90%	9 75%
30 < Change <= 60	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%	3 25%
Change > 60	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%

61. Secondary Outcome

Title	Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Description	QT interval corrected using Fridericia's formula (QTcF) and Bazette's formula (QTcB): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to 480 msec, 480 msec to 500 msec, and more than (>) 500 msec.
Time Frame	Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).

Outcome Measure Data

Analysis Population Description

The QTc analysis set was defined as all enrolled participants who had at least one ECG assessment after receiving study drug or study drugs.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	5	3	3	5	4	3	3	2	3	10	5	2	14	4	7	3	2	10	12
< 450	3 75%	3 60%	3 100%	3 100%	3 60%	1 25%	2 66.7%	2 66.7%	2 66.7%	2 66.7%	7 70%	2 40%	2 100%	11 73.3%	2 50%	5 71.4%	1 33.3%	2 66.7%	5 50%	3 25%
450 <= Value <= 480	1 25%	2 40%	0 0%	0 0%	2 40%	3 75%	1 33.3%	1 33.3%	0 0%	1 33.3%	3 30%	3 60%	0 0%	3 20%	2 50%	1 14.3%	2 66.7%	0 0%	4 40%	7 58.3%
480 < Value <=500	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%
> 500	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	1 10%	0 0%
< 450	4 100%	5 100%	3 100%	3 100%	2 40%	4 100%	3 100%	3 100%	2 66.7%	3 100%	10 100%	4 80%	2 100%	14 93.3%	4 100%	5 71.4%	3 100%	2 66.7%	8 80%	7 58.3%
450 <= Value <= 480	0 0%	0 0%	0 0%	0 0%	3 60%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	1 10%	5 41.7%
480 < Value <=500	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%	0 0%
> 500	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%

62. Secondary Outcome

Title	Percentage of Participants With Objective Response - Arm A
Description	Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel	Arm A2: 110 mg PF-05212384 + Docetaxel	Arm A3: 130 mg PF-05212384 + Docetaxel	Arm A4: 150 mg PF-05212384 + Docetaxel	Arm A5: 180 mg PF-05212384 + Docetaxel
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.	Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
Measure Participants	4	5	3	3	5
Number (95% Confidence Interval) [Percentage of Participants]	0 0%	40 800%	0 0%	66.7 2223.3%	20 400%

63. Secondary Outcome

Title	Percentage of Participants With Objective Response - Arm B
Description	Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm B1: 90 mg PF-05212384 + Cisplatin	Arm B2: 110 mg PF-05212384 + Cisplatin	Arm B3: 130 mg PF-05212384 + Cisplatin	Arm B4: 150 mg PF-05212384 + Cisplatin	Arm B5: 180 mg PF-05212384 + Cisplatin	Arm B6: 215 mg PF-05212384 + Cisplatin	Arm B7: 260 mg PF-05212384 + Cisplatin	Arm B8: 310 mg PF-05212384 + Cisplatin
Arm/Group Description	Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.	Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
Measure Participants	4	3	3	3	3	10	5	2
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%	33.3 666%	66.7 2223.3%	66.7 2223.3%	33.3 666%	20.0 500%	20.0 666.7%	50.0 1666.7%

64. Secondary Outcome

Title	Percentage of Participants With Objective Response - Arm C
Description	Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib	Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib	Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib	Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib	Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Arm/Group Description	Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.	Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
Measure Participants	15	4	7	3	3
Number (95% Confidence Interval) [Percentage of Participants]	20.0 500%	25.0 500%	14.3 476.7%	0 0%	33.3 666%

65. Secondary Outcome

Title	Clinical Benefit Response Rate - Arm B Expansion
Description	Percent of participants with confirmed complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. SD was defined as not qualifying for CR, PR, Progressive Disease (PD).
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	12
Number (95% Confidence Interval) [Percentage of participants]	60.0 1500%	50.0 1000%

66. Secondary Outcome

Title	Duration of Response - Arm B Expansion
Description	Duration of response was calculated from first date of partial response (PR) or complete response (CR) to the date of progression or death due to any cause. In the event of no progression or death, the last tumor assessment date without progression was used in this calculation.
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, had an adequate baseline tumor assessment, and who with objective response.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	4	4
Median (95% Confidence Interval) [month]	6.9	NA

67. Secondary Outcome

Title	Progression Free Survival - Arm B Expansion
Description	Progression free survival (PFS) defined as the time from first dose of study treatment to date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as first event date minus the date of first dose of study medication plus 1 . Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame	Baseline up to 18 months.

Outcome Measure Data

Analysis Population Description

The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	10	12
Median (95% Confidence Interval) [month]	4.8	8.5

68. Secondary Outcome

Title	Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Description	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Time Frame	Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment on study drug and who completed a baseline assessment and at least one post baseline assessment.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	8	11
Baseline	64.58 (18.232)	58.33 (19.003)
Cycle 1 Day 8	50.00 (23.570)	50.00 (26.058)
Cycle 2 Day 1	53.12 (28.499)	56.82 (17.802)
Cycle 2 Day 8	50.00 (25.911)	52.38 (12.468)
Cycle 3 Day 1	56.25 (38.112)	57.41 (16.896)
Cycle 4 Day 1	45.84 (31.551)	48.15 (19.886)
Cycle 5 Day 1	45.00 (32.059)	51.04 (23.753)
Cycle 6 Day 1	55.00 (33.125)	51.39 (15.293)
Cycle 7 Day 1	46.67 (26.745)	52.78 (20.185)
Cycle 8 Day 1	51.67 (25.274)	44.44 (20.860)
Cycle 9 Day 1	56.25 (20.835)	56.25 (24.883)
Cycle 10 Day 1	66.67 (16.665)	56.25 (15.778)
Cycle 11 Day 1	54.17 (17.678)	54.17 (20.971)
Cycle 12 Day 1	62.50 (29.458)	52.08 (23.936)
Cycle 13 Day 1	NA (NA)	63.89 (17.346)
Cycle 14 Day 1	NA (NA)	58.33 (25.000)
Cycle 15 Day 1	NA (NA)	61.11 (19.243)
Cycle 16 Day 1	NA (NA)	55.56 (9.624)

69. Secondary Outcome

Title	Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Description	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Time Frame	Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.

Outcome Measure Data

Analysis Population Description

All enrolled participants who started treatment on study drug and who completed a baseline assessment and at least one post baseline assessment.

Arm/Group Title	Arm 1: 1L Metastasic	Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.	Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
Measure Participants	8	11
Cycle 1 Day 8	-16.67 (23.570)	-9.17 (16.411)
Cycle 2 Day 1	-11.46 (24.372)	-1.52 (9.734)
Cycle 2 Day 8	-14.28 (26.665)	-7.14 (25.200)
Cycle 3 Day 1	-10.42 (33.591)	1.85 (18.054)
Cycle 4 Day 1	-14.58 (29.165)	-7.41 (20.601)
Cycle 5 Day 1	-21.67 (34.660)	-5.21 (30.839)
Cycle 6 Day 1	-11.67 (24.719)	-8.33 (22.361)
Cycle 7 Day 1	-20.00 (26.743)	0.00 (10.545)
Cycle 8 Day 1	-15.00 (18.063)	-8.33 (31.178)
Cycle 9 Day 1	-4.16 (20.971)	-4.16 (22.047)
Cycle 10 Day 1	5.55 (25.458)	-4.16 (30.808)
Cycle 11 Day 1	0.01 (23.568)	-6.25 (24.883)
Cycle 12 Day 1	8.34 (35.348)	-8.34 (32.631)
Cycle 13 Day 1	NA (NA)	0.00 (30.044)
Cycle 14 Day 1	NA (NA)	-5.56 (39.381)
Cycle 15 Day 1	NA (NA)	-2.78 (29.264)
Cycle 16 Day 1	NA (NA)	-8.33 (22.049)

Adverse Events

Time Frame	Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Adverse Event Reporting Description	Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
Arm/Group Title	Arm A1: 90 mg PF-05212384 + Docetaxel		Arm A2: 110 mg PF-05212384 + Docetaxel		Arm A3: 130 mg PF-05212384 + Docetaxel		Arm A4: 150 mg PF-05212384 + Docetaxel		Arm A5: 180 mg PF-05212384 + Docetaxel		Arm B1: 90 mg PF-05212384 + Cisplatin		Arm B2: 110 mg PF-05212384 + Cisplatin		Arm B3: 130 mg PF-05212384 + Cisplatin		Arm B4: 150 mg PF-05212384 + Cisplatin		Arm B5: 180 mg PF-05212384 + Cisplatin		Arm B6: 215 mg PF-05212384 + Cisplatin		Arm B7: 260 mg PF-05212384 + Cisplatin		Arm B8: 310 mg PF-05212384 + Cisplatin		Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib		Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib		Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib		Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib		Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib		Arm 1: 1L Metastatic		Arm 2: 2L/3L Metastatic
Arm/Group Description	Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.		Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.		Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.		Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.		Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.		Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.		Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.		Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.		Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.		Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.		Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.		Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.		Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
All Cause Mortality
	Arm A1: 90 mg PF-05212384 + Docetaxel		Arm A2: 110 mg PF-05212384 + Docetaxel		Arm A3: 130 mg PF-05212384 + Docetaxel		Arm A4: 150 mg PF-05212384 + Docetaxel		Arm A5: 180 mg PF-05212384 + Docetaxel		Arm B1: 90 mg PF-05212384 + Cisplatin		Arm B2: 110 mg PF-05212384 + Cisplatin		Arm B3: 130 mg PF-05212384 + Cisplatin		Arm B4: 150 mg PF-05212384 + Cisplatin		Arm B5: 180 mg PF-05212384 + Cisplatin		Arm B6: 215 mg PF-05212384 + Cisplatin		Arm B7: 260 mg PF-05212384 + Cisplatin		Arm B8: 310 mg PF-05212384 + Cisplatin		Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib		Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib		Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib		Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib		Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib		Arm 1: 1L Metastatic		Arm 2: 2L/3L Metastatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		2/4 (50%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Serious Adverse Events
	Arm A1: 90 mg PF-05212384 + Docetaxel		Arm A2: 110 mg PF-05212384 + Docetaxel		Arm A3: 130 mg PF-05212384 + Docetaxel		Arm A4: 150 mg PF-05212384 + Docetaxel		Arm A5: 180 mg PF-05212384 + Docetaxel		Arm B1: 90 mg PF-05212384 + Cisplatin		Arm B2: 110 mg PF-05212384 + Cisplatin		Arm B3: 130 mg PF-05212384 + Cisplatin		Arm B4: 150 mg PF-05212384 + Cisplatin		Arm B5: 180 mg PF-05212384 + Cisplatin		Arm B6: 215 mg PF-05212384 + Cisplatin		Arm B7: 260 mg PF-05212384 + Cisplatin		Arm B8: 310 mg PF-05212384 + Cisplatin		Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib		Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib		Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib		Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib		Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib		Arm 1: 1L Metastatic		Arm 2: 2L/3L Metastatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/4 (50%)		2/5 (40%)		0/3 (0%)		1/3 (33.3%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		1/3 (33.3%)		3/3 (100%)		3/3 (100%)		4/10 (40%)		2/5 (40%)		2/2 (100%)		3/15 (20%)		2/4 (50%)		3/7 (42.9%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		4/12 (33.3%)
Blood and lymphatic system disorders
Febrile neutropenia	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Anaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ear and labyrinth disorders
Vertigo	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Gastrointestinal disorders
Nausea	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Stomatitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vomiting	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Upper gastrointestinal haemorrhage	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
General disorders
Disease progression	0/4 (0%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Mucosal inflammation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Fatigue	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pyrexia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infections and infestations
Gastroenteritis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pneumonia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Sepsis	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Device related infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infectious mononucleosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lower respiratory tract infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pneumonia influenzal	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Urinary tract infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vascular device infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Investigations
Blood creatinine increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Platelet count decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Metabolism and nutrition disorders
Dehydration	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypomagnesaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Back pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nervous system disorders
Epilepsy	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Psychiatric disorders
Depression	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Renal and urinary disorders
Acute kidney injury	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Dyspnoea exertional	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Respiratory failure	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pulmonary embolism	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Haemoptysis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vascular disorders
Deep vein thrombosis	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Arm A1: 90 mg PF-05212384 + Docetaxel		Arm A2: 110 mg PF-05212384 + Docetaxel		Arm A3: 130 mg PF-05212384 + Docetaxel		Arm A4: 150 mg PF-05212384 + Docetaxel		Arm A5: 180 mg PF-05212384 + Docetaxel		Arm B1: 90 mg PF-05212384 + Cisplatin		Arm B2: 110 mg PF-05212384 + Cisplatin		Arm B3: 130 mg PF-05212384 + Cisplatin		Arm B4: 150 mg PF-05212384 + Cisplatin		Arm B5: 180 mg PF-05212384 + Cisplatin		Arm B6: 215 mg PF-05212384 + Cisplatin		Arm B7: 260 mg PF-05212384 + Cisplatin		Arm B8: 310 mg PF-05212384 + Cisplatin		Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib		Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib		Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib		Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib		Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib		Arm 1: 1L Metastatic		Arm 2: 2L/3L Metastatic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		5/5 (100%)		3/3 (100%)		3/3 (100%)		5/5 (100%)		4/4 (100%)		3/3 (100%)		3/3 (100%)		3/3 (100%)		3/3 (100%)		10/10 (100%)		5/5 (100%)		2/2 (100%)		15/15 (100%)		4/4 (100%)		7/7 (100%)		3/3 (100%)		3/3 (100%)		10/10 (100%)		12/12 (100%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)		2/5 (40%)		0/3 (0%)		1/3 (33.3%)		2/5 (40%)		2/4 (50%)		1/3 (33.3%)		1/3 (33.3%)		2/3 (66.7%)		2/3 (66.7%)		7/10 (70%)		3/5 (60%)		2/2 (100%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		8/10 (80%)		11/12 (91.7%)
Leukopenia	0/4 (0%)		3/5 (60%)		1/3 (33.3%)		1/3 (33.3%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		5/10 (50%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		2/12 (16.7%)
Lymphopenia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Neutropenia	4/4 (100%)		4/5 (80%)		2/3 (66.7%)		3/3 (100%)		5/5 (100%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)		5/10 (50%)		1/5 (20%)		1/2 (50%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		5/10 (50%)		6/12 (50%)
Thrombocytopenia	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lymphocytosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Iron deficiency anaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Thrombocytosis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cardiac disorders
Tachycardia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Palpitations	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Sinus bradycardia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Atrial fibrillation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Bradycardia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ear and labyrinth disorders
Deafness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Deafness neurosensory	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ear pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Ototoxicity	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Tinnitus	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		4/10 (40%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		1/12 (8.3%)
Motion sickness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vertigo	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Endocrine disorders
Hyperthyroidism	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Eye disorders
Blindness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Keratitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ocular hyperaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Photopsia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vision blurred	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Visual impairment	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Chalazion	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lacrimation increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Dry eye	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Extraocular muscle paresis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Eye pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Periorbital oedema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Swelling of eyelid	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Visual acuity reduced	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Abdominal pain	1/4 (25%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		2/10 (20%)		1/12 (8.3%)
Constipation	2/4 (50%)		3/5 (60%)		1/3 (33.3%)		2/3 (66.7%)		1/5 (20%)		3/4 (75%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		4/10 (40%)		2/5 (40%)		2/2 (100%)		3/15 (20%)		1/4 (25%)		2/7 (28.6%)		1/3 (33.3%)		1/3 (33.3%)		9/10 (90%)		4/12 (33.3%)
Diarrhoea	2/4 (50%)		1/5 (20%)		1/3 (33.3%)		2/3 (66.7%)		2/5 (40%)		0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		5/10 (50%)		1/5 (20%)		1/2 (50%)		9/15 (60%)		4/4 (100%)		6/7 (85.7%)		2/3 (66.7%)		2/3 (66.7%)		2/10 (20%)		5/12 (41.7%)
Dry mouth	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		2/3 (66.7%)		0/3 (0%)		1/10 (10%)		2/12 (16.7%)
Dyspepsia	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		3/10 (30%)		0/5 (0%)		1/2 (50%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		3/10 (30%)		1/12 (8.3%)
Dysphagia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		2/4 (50%)		1/7 (14.3%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		0/12 (0%)
Gastrooesophageal reflux disease	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Haemorrhoids	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Nausea	2/4 (50%)		0/5 (0%)		3/3 (100%)		1/3 (33.3%)		3/5 (60%)		3/4 (75%)		2/3 (66.7%)		3/3 (100%)		2/3 (66.7%)		2/3 (66.7%)		9/10 (90%)		3/5 (60%)		2/2 (100%)		9/15 (60%)		3/4 (75%)		4/7 (57.1%)		2/3 (66.7%)		2/3 (66.7%)		7/10 (70%)		9/12 (75%)
Oral pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Proctalgia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Stomatitis	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		2/5 (40%)		1/2 (50%)		1/15 (6.7%)		0/4 (0%)		2/7 (28.6%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		5/12 (41.7%)
Vomiting	1/4 (25%)		0/5 (0%)		0/3 (0%)		2/3 (66.7%)		2/5 (40%)		2/4 (50%)		1/3 (33.3%)		2/3 (66.7%)		2/3 (66.7%)		2/3 (66.7%)		8/10 (80%)		1/5 (20%)		2/2 (100%)		6/15 (40%)		4/4 (100%)		1/7 (14.3%)		1/3 (33.3%)		2/3 (66.7%)		6/10 (60%)		8/12 (66.7%)
Abdominal pain upper	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		3/15 (20%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Gingival recession	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Glossodynia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Impaired gastric emptying	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lip disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Mouth ulceration	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Odynophagia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Oesophagitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oral disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oral dysaesthesia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Periodontal disease	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Proctitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Toothache	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Anal pruritus	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Faeces discoloured	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Faeces soft	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Flatulence	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Haematochezia	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rectal haemorrhage	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Salivary hypersecretion	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cheilitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cheilosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Intestinal obstruction	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lip pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Melaena	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oesophageal pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Paraesthesia oral	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Regurgitation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Aphthous ulcer	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Gingival bleeding	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Hypoaesthesia oral	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Oral mucosal blistering	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Oral mucosal erythema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Tongue dry	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
General disorders
Asthenia	0/4 (0%)		3/5 (60%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		5/10 (50%)		0/5 (0%)		2/2 (100%)		2/15 (13.3%)		0/4 (0%)		2/7 (28.6%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		3/12 (25%)
Chills	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Fatigue	1/4 (25%)		1/5 (20%)		1/3 (33.3%)		3/3 (100%)		2/5 (40%)		2/4 (50%)		1/3 (33.3%)		3/3 (100%)		1/3 (33.3%)		1/3 (33.3%)		5/10 (50%)		3/5 (60%)		1/2 (50%)		9/15 (60%)		1/4 (25%)		4/7 (57.1%)		1/3 (33.3%)		0/3 (0%)		7/10 (70%)		9/12 (75%)
Gait disturbance	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Mucosal inflammation	2/4 (50%)		3/5 (60%)		1/3 (33.3%)		2/3 (66.7%)		4/5 (80%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		3/3 (100%)		1/3 (33.3%)		8/10 (80%)		3/5 (60%)		2/2 (100%)		12/15 (80%)		4/4 (100%)		6/7 (85.7%)		2/3 (66.7%)		3/3 (100%)		6/10 (60%)		7/12 (58.3%)
Oedema peripheral	0/4 (0%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Pyrexia	2/4 (50%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		0/5 (0%)		2/2 (100%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		2/3 (66.7%)		0/3 (0%)		6/10 (60%)		5/12 (41.7%)
Catheter site dermatitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Catheter site rash	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Chest discomfort	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infusion site pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Non-cardiac chest pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Peripheral swelling	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Chest pain	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Face oedema	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Feeling cold	2/4 (50%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Malaise	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pain	2/4 (50%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Catheter site erythema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Early satiety	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Facial pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infusion site extravasation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Oedema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Puncture site pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Secretion discharge	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Swelling	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		2/3 (66.7%)		0/10 (0%)		0/12 (0%)
Axillary pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Catheter site irritation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Infusion site pruritus	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hepatobiliary disorders
Hepatic pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Hepatomegaly	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Immune system disorders
Hypersensitivity	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Anaphylactic reaction	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Infections and infestations
Conjunctivitis	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		2/15 (13.3%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Lower respiratory tract infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nasopharyngitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/5 (20%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Paronychia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		5/15 (33.3%)		1/4 (25%)		3/7 (42.9%)		3/3 (100%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Urinary tract infection	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		3/15 (20%)		1/4 (25%)		1/7 (14.3%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		2/12 (16.7%)
Catheter site infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Clostridium difficile colitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ear infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Herpes simplex	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Herpes zoster	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lymphangitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nail bed infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oral candidiasis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pharyngitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		2/12 (16.7%)
Sinusitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Vascular device infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cystitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Folliculitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Oral herpes	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pneumonia	0/4 (0%)		2/5 (40%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Rash pustular	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rhinitis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Skin infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Upper respiratory tract infection	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		1/7 (14.3%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Bronchitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cellulitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Ecthyma	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Eyelid folliculitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infected cyst	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Periodontitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Tooth infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Viral infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vulvitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vulvovaginal candidiasis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Candida infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Localised infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Tooth abscess	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Fall	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Infusion related reaction	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Skin abrasion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Wound dehiscence	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Procedural pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Post procedural haemorrhage	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Skin laceration	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Investigations
Alanine aminotransferase increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		1/12 (8.3%)
Blood creatinine increased	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		1/2 (50%)		0/15 (0%)		1/4 (25%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		5/12 (41.7%)
Blood urea increased	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Lymphocyte count decreased	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		3/10 (30%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		4/10 (40%)		2/12 (16.7%)
Neutrophil count decreased	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		2/12 (16.7%)
Weight decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		2/15 (13.3%)		1/4 (25%)		3/7 (42.9%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		4/12 (33.3%)
White blood cell count decreased	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		4/10 (40%)		5/12 (41.7%)
Blood creatine increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood magnesium decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood phosphorus decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood potassium decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Body temperature increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Platelet count	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Platelet count decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/5 (20%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Staphylococcus test positive	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Aspartate aminotransferase increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		0/12 (0%)
Blood alkaline phosphatase increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood bilirubin increased	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood lactate dehydrogenase increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Gamma-glutamyltransferase increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Blood calcium increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Electrocardiogram QT prolonged	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Haemoglobin decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
International normalised ratio increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Creatinine renal clearance abnormal	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Glycosylated haemoglobin increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Grip strength decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Haematocrit decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Human epidermal growth factor receptor decreased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Metabolism and nutrition disorders
Decreased appetite	0/4 (0%)		1/5 (20%)		2/3 (66.7%)		1/3 (33.3%)		1/5 (20%)		0/4 (0%)		2/3 (66.7%)		3/3 (100%)		0/3 (0%)		1/3 (33.3%)		5/10 (50%)		1/5 (20%)		0/2 (0%)		7/15 (46.7%)		0/4 (0%)		2/7 (28.6%)		1/3 (33.3%)		2/3 (66.7%)		1/10 (10%)		2/12 (16.7%)
Dehydration	1/4 (25%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		4/15 (26.7%)		3/4 (75%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hyperglycaemia	1/4 (25%)		1/5 (20%)		2/3 (66.7%)		0/3 (0%)		3/5 (60%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		4/10 (40%)		1/5 (20%)		2/2 (100%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		3/12 (25%)
Hypokalaemia	2/4 (50%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		2/4 (50%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		3/12 (25%)
Hyponatraemia	0/4 (0%)		1/5 (20%)		1/3 (33.3%)		1/3 (33.3%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		2/10 (20%)		2/5 (40%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Hypophosphataemia	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		2/3 (66.7%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		2/4 (50%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/12 (8.3%)
Hyperphosphataemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hyperuricaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Hypochloraemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Hypomagnesaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		1/3 (33.3%)		2/3 (66.7%)		2/3 (66.7%)		1/3 (33.3%)		6/10 (60%)		1/5 (20%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		3/10 (30%)		6/12 (50%)
Hypercalcaemia	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypocalcaemia	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		2/12 (16.7%)
Malnutrition	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Metabolic acidosis	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypoalbuminaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Fluid overload	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Fluid retention	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Hypercholesterolaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Hyperkalaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		2/5 (40%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/12 (8.3%)
Back pain	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		2/4 (50%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		2/4 (50%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Joint swelling	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Musculoskeletal pain	1/4 (25%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		2/15 (13.3%)		3/4 (75%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Pain in extremity	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		2/3 (66.7%)		1/10 (10%)		0/12 (0%)
Flank pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Muscle spasms	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		1/4 (25%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		1/12 (8.3%)
Muscular weakness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/5 (40%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Neck pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Spinal pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Bone pain	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Groin pain	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Myalgia	1/4 (25%)		0/5 (0%)		0/3 (0%)		2/3 (66.7%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Limb discomfort	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Synovitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Musculoskeletal stiffness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Plantar fasciitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Metastases to meninges	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Cancer pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Nervous system disorders
Dizziness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		2/5 (40%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		2/4 (50%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Dysarthria	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Dysgeusia	0/4 (0%)		2/5 (40%)		3/3 (100%)		1/3 (33.3%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)		0/3 (0%)		3/10 (30%)		1/5 (20%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		1/3 (33.3%)		5/10 (50%)		4/12 (33.3%)
Headache	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		3/10 (30%)		1/5 (20%)		1/2 (50%)		4/15 (26.7%)		1/4 (25%)		1/7 (14.3%)		1/3 (33.3%)		0/3 (0%)		3/10 (30%)		1/12 (8.3%)
Neuropathy peripheral	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		1/5 (20%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Paraesthesia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/5 (40%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		2/10 (20%)		2/12 (16.7%)
Taste disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Dysaesthesia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Dystonia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Extrapyramidal disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Migraine	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Peripheral sensory neuropathy	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Speech disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Syncope	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Transient ischaemic attack	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Tremor	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypoaesthesia	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lethargy	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Drooling	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Visual field defect	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Product Issues
Device dislocation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Device occlusion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Psychiatric disorders
Anxiety	0/4 (0%)		1/5 (20%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Insomnia	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		1/12 (8.3%)
Confusional state	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Depression	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Mental status changes	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Panic attack	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Delirium	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Depressed mood	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Mental disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Renal and urinary disorders
Dysuria	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/12 (0%)
Acute kidney injury	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Haematuria	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Cystitis haemorrhagic	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Micturition disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Pollakiuria	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Glycosuria	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Renal disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Renal failure	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Reproductive system and breast disorders
Vulvovaginal inflammation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Vulvovaginal pruritus	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oedema genital	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vaginal discharge	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		2/4 (50%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vaginal haemorrhage	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Vulvovaginal dryness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Breast pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Cough	2/4 (50%)		2/5 (40%)		1/3 (33.3%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		3/3 (100%)		1/3 (33.3%)		2/10 (20%)		0/5 (0%)		0/2 (0%)		3/15 (20%)		1/4 (25%)		0/7 (0%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		4/12 (33.3%)
Dyspnoea	0/4 (0%)		2/5 (40%)		0/3 (0%)		2/3 (66.7%)		1/5 (20%)		0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		2/10 (20%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Dyspnoea exertional	1/4 (25%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Epistaxis	1/4 (25%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		2/3 (66.7%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		3/12 (25%)
Hiccups	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		2/4 (50%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		2/12 (16.7%)
Nasal inflammation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pleural effusion	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Dysphonia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		1/15 (6.7%)		1/4 (25%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		1/10 (10%)		2/12 (16.7%)
Laryngeal inflammation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nasal congestion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nasal dryness	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oropharyngeal pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		2/10 (20%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		1/7 (14.3%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		3/12 (25%)
Pleuritic pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pulmonary embolism	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rhinorrhoea	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Chronic obstructive pulmonary disease	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rhinitis allergic	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Aphonia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Haemoptysis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypoxia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nasal discomfort	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Oropharyngeal discomfort	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Paranasal sinus hypersecretion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pneumonitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Pneumothorax	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Productive cough	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Throat irritation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Wheezing	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Catarrh	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Upper respiratory tract congestion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Skin and subcutaneous tissue disorders
Dermatitis acneiform	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		8/15 (53.3%)		1/4 (25%)		3/7 (42.9%)		1/3 (33.3%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Dry skin	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		1/2 (50%)		5/15 (33.3%)		1/4 (25%)		1/7 (14.3%)		3/3 (100%)		0/3 (0%)		2/10 (20%)		1/12 (8.3%)
Pruritus	0/4 (0%)		1/5 (20%)		1/3 (33.3%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		2/3 (66.7%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		2/15 (13.3%)		1/4 (25%)		1/7 (14.3%)		3/3 (100%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Rash	0/4 (0%)		3/5 (60%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		7/10 (70%)		2/5 (40%)		2/2 (100%)		5/15 (33.3%)		0/4 (0%)		1/7 (14.3%)		1/3 (33.3%)		0/3 (0%)		2/10 (20%)		5/12 (41.7%)
Rash maculo-papular	0/4 (0%)		1/5 (20%)		1/3 (33.3%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		0/10 (0%)		1/5 (20%)		1/2 (50%)		2/15 (13.3%)		2/4 (50%)		4/7 (57.1%)		1/3 (33.3%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Dermatitis exfoliative generalised	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Dermatomyositis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hyperhidrosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Nail dystrophy	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Prurigo	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rash erythematous	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rash macular	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Skin lesion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Systemic lupus erythematosus rash	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		1/2 (50%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Alopecia	2/4 (50%)		2/5 (40%)		1/3 (33.3%)		3/3 (100%)		3/5 (60%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		3/15 (20%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Erythema	1/4 (25%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Nail discolouration	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Onychoclasis	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Onycholysis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Onychomadesis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Scab	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Skin irritation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Skin toxicity	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Intertrigo	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Onychalgia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Palmar-plantar erythrodysaesthesia syndrome	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Rash papular	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		2/7 (28.6%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Skin fissures	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		3/15 (20%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Skin mass	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Umbilical discharge	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		1/3 (33.3%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Acne	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Ingrowing nail	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Macule	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Nail disorder	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Nail ridging	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Photosensitivity reaction	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		1/12 (8.3%)
Hypertrichosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		2/15 (13.3%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Vascular disorders
Hypertension	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		1/7 (14.3%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Hypotension	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/5 (20%)		0/2 (0%)		1/15 (6.7%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		2/12 (16.7%)
Embolism	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Lymphoedema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)
Phlebitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Hypovolaemic shock	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Thrombophlebitis superficial	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		1/3 (33.3%)		0/10 (0%)		0/12 (0%)
Hot flush	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		1/4 (25%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/12 (0%)
Deep vein thrombosis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/10 (0%)		0/5 (0%)		0/2 (0%)		0/15 (0%)		0/4 (0%)		0/7 (0%)		0/3 (0%)		0/3 (0%)		1/10 (10%)		1/12 (8.3%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.