A Study Of PF-06647263 In Patients With Advanced Solid Tumors

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02078752
• Collaborator: (none)
• Enrollment: 60
• Locations: 10
• Arm: 1
• Actual Duration (Months): 37
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Triple-Negative Breast Cancer	Drug: PF-06647263; Drug: PF-06647263	Phase 1

Detailed Description

The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647263 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
• Actual Study Start Date: Apr 9, 2014
• Actual Primary Completion Date: May 10, 2017
• Actual Study Completion Date: May 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1	Drug: PF-06647263; Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.; Drug: PF-06647263; Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1) [Baseline up to Cycle 2 Day 1 (22 days)]

   DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.

2. Percentage of Participants With Objective Response (Part 2) [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]

   Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.

Secondary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles) [Baseline up to 28 days after the last treatment administration (Approximately 13 months)]

   An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

2. Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles) [Baseline up to 28 days after the last treatment administration (Approximately 13 months)]

   An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

3. Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles) [Baseline up to 28 days after the last treatment administration (Approximately 13 months)]

   A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

4. Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles) [Baseline up to 28 days after the last treatment administration (Approximately 13 months)]

   A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

5. Number of Participants With Vital Signs Abnormalities [Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)]

   Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.

6. Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263 [Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).]

   AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.

7. Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263 [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

   Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.

8. Maximum Observed Serum Concentration (Cmax) of PF-06647263 [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

   Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.

9. Time for Cmax (Tmax) of PF-06647963 [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

   Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.

10. Clearance (CL) of PF-06647263 [QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.

11. Volume of Distribution at Steady State (Vss) of PF-06647263 [QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.

12. Terminal Serum Half-life (t1/2) of PF-06647263 [Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.

13. AUC504 of Total Antibody [Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).]

    AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).

14. AUCtau of Total Antibody [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

15. Cmax of Total Antibody [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

16. Tmax of Total Antibody [QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

17. CL of Total Antibody [QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

18. Vss of Total Antibody [QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

19. t1/2 of Total Antibody [Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.]

    T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

20. Cmax of Unconjugated Payload CL-184538 [Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)]

    Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).

21. Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [Baseline up to 7 days post end of treatment (Approximately 13 months)]

    Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.

22. Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538) [QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.]

    Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.

23. Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody [QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.]

    Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.

24. Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody [QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.]

    Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.

25. Percentage of Participants With Objective Response (Part 1) [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]

    Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.

26. Percentage of Participants With Clinical Benefit Response [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]

    Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.

27. Progression Free Survival [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]

    The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.

28. Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2) [Baseline up to 24 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available

• Performance Status of 0 or 1

• Adequate bone marrow, kidney, and liver function

• Part 2 includes advanced triple negative breast cancer patients.

Exclusion Criteria:

• Brain metastases requiring steroids

• Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start

• Active and clinically significant bacterial, fungal or viral infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham & Women's Hospital (BWH)	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute (DFCI)	Boston	Massachusetts	United States	02215
4	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
5	Comprehensive Cancer Centers Of Nevada	Las Vegas	Nevada	United States	89169
6	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
7	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37203
8	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Huntsman Cancer Hospital / University of Utah	Salt Lake City	Utah	United States	84112
10	Huntsman Cancer Institute-University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Aug 17, 2016
• Statistical Analysis Plan - Apr 11, 2014

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: NCT02078752
• Other Study ID Numbers: B7521001
• First Posted: Mar 5, 2014
• Last Update Posted: Apr 29, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: ADC; PF-06647263; solid tumors; tumors; neoplasm metastasis; TNBC; Triple negative breast cancer
• Additional relevant MeSH terms: Triple Negative Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Period Title: Overall Study
STARTED	3	13	2	7	3	9	3	6	2	12
COMPLETED	1	6	1	5	2	5	1	3	2	2
NOT COMPLETED	2	7	1	2	1	4	2	3	0	10

Baseline Characteristics

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)	Total
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	Total of all reporting groups
Overall Participants	3	13	2	7	3	9	3	6	2	12	60
Age, Customized (Count of Participants)
18-44	0 0%	2 15.4%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 50%	1 8.3%	4 6.7%
45-64	2 66.7%	4 30.8%	2 100%	6 85.7%	3 100%	9 100%	1 33.3%	3 50%	0 0%	8 66.7%	38 63.3%
>=65	1 33.3%	7 53.8%	0 0%	1 14.3%	0 0%	0 0%	2 66.7%	3 50%	1 50%	3 25%	18 30%
Sex: Female, Male (Count of Participants)
Female	3 100%	12 92.3%	2 100%	7 100%	3 100%	7 77.8%	2 66.7%	4 66.7%	2 100%	12 100%	54 90%
Male	0 0%	1 7.7%	0 0%	0 0%	0 0%	2 22.2%	1 33.3%	2 33.3%	0 0%	0 0%	6 10%
Race/Ethnicity, Customized (Count of Participants)
White	2 66.7%	11 84.6%	1 50%	6 85.7%	3 100%	5 55.6%	2 66.7%	6 100%	2 100%	10 83.3%	48 80%
Black	1 33.3%	2 15.4%	1 50%	1 14.3%	0 0%	1 11.1%	0 0%	0 0%	0 0%	0 0%	6 10%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%	0 0%	2 16.7%	3 5%
Other	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 33.3%	0 0%	0 0%	0 0%	2 3.3%
Unspecified	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%	0 0%	0 0%	1 1.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)
Description	DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.
Time Frame	Baseline up to Cycle 2 Day 1 (22 days)

Outcome Measure Data

Analysis Population Description

The analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Measure Participants	3	13	2	7	3	9	3	6	2
Count of Participants [Participants]	0 0%	1 7.7%	0 0%	1 14.3%	0 0%	2 22.2%	0 0%	2 33.3%	2 100%

2. Primary Outcome

Title	Percentage of Participants With Objective Response (Part 2)
Description	Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Time Frame	Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Outcome Measure Data

Analysis Population Description

The analysis set included all treated participants in Part 2 with measurable disease at baseline.

Arm/Group Title	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	12
Number (95% Confidence Interval) [Percentage of Participants]	8.3 276.7%

3. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)
Description	An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame	Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Count of Participants [Participants]	3 100%	13 100%	2 100%	7 100%	3 100%	9 100%	3 100%	6 100%	2 100%	12 100%

4. Secondary Outcome

Title	Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)
Description	An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame	Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Number [Participants]	3 100%	11 84.6%	2 100%	7 100%	3 100%	9 100%	3 100%	5 83.3%	2 100%	8 66.7%

5. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)
Description	A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame	Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Number [Participants]	1 33.3%	6 46.2%	0 0%	0 0%	1 33.3%	1 11.1%	1 33.3%	3 50%	1 50%	4 33.3%

6. Secondary Outcome

Title	Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)
Description	A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Time Frame	Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Number [Participants]	0 0%	1 7.7%	0 0%	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 50%	1 8.3%

7. Secondary Outcome

Title	Number of Participants With Vital Signs Abnormalities
Description	Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.
Time Frame	Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Sitting systolic blood pressure (SBP) <90	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 33.3%	1 16.7%	0 0%	1 8.3%
Sitting diastolic blood pressure (DBP) <50	1 33.3%	0 0%	0 0%	3 42.9%	0 0%	1 11.1%	1 33.3%	2 33.3%	0 0%	0 0%
Sitting pulse rate <40	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sitting pulse rate >120	1 33.3%	1 7.7%	0 0%	0 0%	1 33.3%	0 0%	1 33.3%	0 0%	0 0%	1 8.3%
Max increase from baseline in sitting SBP >=30	0 0%	0 0%	0 0%	1 14.3%	1 33.3%	0 0%	0 0%	1 16.7%	0 0%	1 8.3%
Max increase from baseline in sitting DBP >=20	0 0%	1 7.7%	0 0%	1 14.3%	1 33.3%	0 0%	0 0%	1 16.7%	0 0%	2 16.7%
Max decrease from baseline in sitting SBP >=30	1 33.3%	5 38.5%	2 100%	2 28.6%	1 33.3%	1 11.1%	2 66.7%	2 33.3%	1 50%	0 0%
Max decrease from baseline in sitting DBP >=20	1 33.3%	3 23.1%	1 50%	1 14.3%	0 0%	1 11.1%	2 66.7%	2 33.3%	1 50%	0 0%

8. Secondary Outcome

Title	Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263
Description	AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.
Time Frame	Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).

Outcome Measure Data

Analysis Population Description

The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	10	6	8
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	2299 (41)	2777 (26)	3958 (45)	3414 (23)

9. Secondary Outcome

Title	Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263
Description	Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	594.1 (38)	544.8 (28)	NA (NA)	1056 (31)	1246 (56)	3475 (36)	6023 (35)	6363 (18)	NA (NA)	669.9 (31)
Cycle 1 Day 15	927.8 (33)	1166 (37)	NA (NA)	1274 (30)
Cycle 4 Day 1	NA (NA)	4617 (42)	NA (NA)	NA (NA)

10. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of PF-06647263
Description	Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	12.64 (20)	11.96 (26)	NA (NA)	22.63 (24)	25.41 (60)	58.25 (40)	84.40 (38)	101.6 (34)	NA (NA)	16.86 (29)
Cycle 1 Day 15	11.86 (33)	13.73 (47)	27.45 (48)	17.84 (25)
Cycle 4 Day 1	NA (NA)	41.98 (16)	NA (NA)	NA (NA)

11. Secondary Outcome

Title	Time for Cmax (Tmax) of PF-06647963
Description	Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	1.00	1.00	2.52	1.00	1.00	1.00	3.97	1.05	1.03	1.00
Cycle 1 Day 15	1.00	1.00	1.00	1.00
Cycle 4 Day 1	2.55	1.08	2.60	1.56

12. Secondary Outcome

Title	Clearance (CL) of PF-06647263
Description	For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.
Time Frame	QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	NA (NA)	1.547 (33)	1.108 (24)	0.9244 (43)	0.9219 (39)	NA (NA)
Cycle 1 Day 15	0.7932 (15)	0.9454 (31)	NA (NA)	0.8451 (27)
Cycle 4 Day 1	NA (NA)	0.6904 (36)	NA (NA)	NA (NA)

13. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) of PF-06647263
Description	Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.
Time Frame	QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	NA (NA)	162.7 (44)	114.8 (20)	134.0 (49)	116.5 (56)	NA (NA)
Cycle 1 Day 15	84.01 (28)	102.3 (49)	NA (NA)	72.31 (21)
Cycle 4 Day 1	NA (NA)	105.7 (18)	NA (NA)	NA (NA)

14. Secondary Outcome

Title	Terminal Serum Half-life (t1/2) of PF-06647263
Description	T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.
Time Frame	Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)
Arm/Group Description	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Measure Participants	2	3	9	3	6	2
Cycle 1 Day 1	NA (NA)	4.403 (0.593)	3.541 (0.756)	5.353 (0.542)	4.336 (1.02)	NA (NA)
Cycle 4 Day 1	NA (NA)	5.100 (1.56)	NA (NA)	NA (NA)

15. Secondary Outcome

Title	AUC504 of Total Antibody
Description	AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Time Frame	Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).

Outcome Measure Data

Analysis Population Description

The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	11	4	8
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	50080 (38)	64190 (26)	91730 (19)	74250 (40)

16. Secondary Outcome

Title	AUCtau of Total Antibody
Description	Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	12140 (29)	11780 (32)	NA (NA)	18900 (26)	38330 (63)	81710 (45)	173000 (39)	164400 (22)	NA (NA)	13950 (29)
Cycle 1 Day 15	21620 (30)	29740 (33)	NA (NA)	32760 (39)
Cycle 4 Day 1	NA (NA)	155800 (62)	NA (NA)	NA (NA)

17. Secondary Outcome

Title	Cmax of Total Antibody
Description	Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	209.1 (23)	187.7 (23)	NA (NA)	357.2 (20)	482.9 (52)	865.9 (32)	1475 (45)	1622 (32)	NA (NA)	265.3 (27)
Cycle 1 Day 15	229.6 (25)	282.7 (32)	506.5 (44)	305 (32)
Cycle 4 Day 1	NA (NA)	813 (32)	NA (NA)	NA (NA)

18. Secondary Outcome

Title	Tmax of Total Antibody
Description	Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	1.00	1.00	1.00	1.00	1.00	1.00	1.05	1.08	3.81	1.00
Cycle 1 Day 15	1.00	1.00	1.00	1.00
Cycle 4 Day 1	2.55	1.08	2.60	2.55

19. Secondary Outcome

Title	CL of Total Antibody
Description	For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	NA (NA)	0.04455 (43)	0.04947 (17)	NA (NA)	0.03471 (33)
Cycle 1 Day 15	0.03411 (5)	0.03736 (35)	NA (NA)	0.03447 (48)
Cycle 4 Day 1	NA (NA)	0.02049 (45)	NA (NA)	NA (NA)

20. Secondary Outcome

Title	Vss of Total Antibody
Description	Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Cycle 1 Day 1	NA (NA)	10.32 (32)	10.96 (17)	NA (NA)	8.074 (51)
Cycle 1 Day 15	NA (NA)	NA (NA)	NA (NA)
Cycle 4 Day 1	NA (NA)

21. Secondary Outcome

Title	t1/2 of Total Antibody
Description	T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Time Frame	Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Arm/Group Title	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)
Arm/Group Description	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Measure Participants	2	3	9	3	6	2
Cycle 1 Day 1	NA (NA)	7.860 (0.581)	7.587 (2.34)	NA (NA)	7.713 (1.52)
Cycle 4 Day 1	NA (NA)

22. Secondary Outcome

Title	Cmax of Unconjugated Payload CL-184538
Description	Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Time Frame	Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The analysis set was defined as enrolled patients who were analyzed for pharmacokinetics.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

23. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Description	Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.
Time Frame	Baseline up to 7 days post end of treatment (Approximately 13 months)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Count of Participants [Participants]	2 66.7%	12 92.3%	2 100%	7 100%	3 100%	9 100%	3 100%	6 100%	2 100%	11 91.7%

24. Secondary Outcome

Title	Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538)
Description	Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.
Time Frame	QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Positive Anti-PF-06647263	2 66.7%	5 38.5%	0 0%	4 57.1%	2 66.7%	4 44.4%	1 33.3%	1 16.7%	0 0%	8 66.7%
Positive Anti PF-06523432	0 0%	3 23.1%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%
Positive Anti CL-184538	2 66.7%	5 38.5%	2 100%	2 28.6%	4 133.3%	1 11.1%	0 0%	6 100%

25. Secondary Outcome

Title	Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody
Description	Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.
Time Frame	QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Outcome Measure Data

Analysis Population Description

The analysis set included all participants who were treated and tested for that parameter.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	2	5	0	4	2	4	1	1	0	8
Count of Participants [Participants]	2 66.7%	5 38.5%	3 150%	2 28.6%	3 100%	1 11.1%	0 0%	8 133.3%

26. Secondary Outcome

Title	Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody
Description	Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.
Time Frame	QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Outcome Measure Data

Analysis Population Description

"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	3	13	2	7	3	9	3	6	2	12
Treatment-emergent	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%
Treatment-boosted	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

27. Secondary Outcome

Title	Percentage of Participants With Objective Response (Part 1)
Description	Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Time Frame	Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Outcome Measure Data

Analysis Population Description

The analysis set included treated participants with measurable disease at baseline.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Measure Participants	2	11	1	6	3	7	3	6	2
Number (95% Confidence Interval) [Percentage of participants]	0 0%	9.1 70%	0 0%	16.7 238.6%	0 0%	14.3 158.9%	66.7 2223.3%	0 0%	0 0%

28. Secondary Outcome

Title	Percentage of Participants With Clinical Benefit Response
Description	Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.
Time Frame	Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Outcome Measure Data

Analysis Population Description

The analysis set included the number of participants with measurable disease at baseline.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	2	11	1	6	3	7	3	6	2	12
Number (95% Confidence Interval) [Percentage of participants]	50.0 1666.7%	36.4 280%	0 0%	16.7 238.6%	33.3 1110%	42.9 476.7%	66.7 2223.3%	16.7 278.3%	0 0%	25.0 208.3%

29. Secondary Outcome

Title	Progression Free Survival
Description	The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.
Time Frame	Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Outcome Measure Data

Analysis Population Description

The analysis set included the number of participants with event.

Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg QW (Part 1)	PF-06647263 0.015 mg/kg Q3W (Part 1)	PF-06647263 0.02 mg/kg QW (Part 1)	PF-06647263 0.03 mg/kg Q3W (Part 1)	PF-06647263 0.05 mg/kg Q3W (Part 1)	PF-06647263 0.075 mg/kg Q3W (Part 1)	PF-06647263 0.1 mg/kg Q3W (Part 1)	PF-06647263 0.134 mg/kg Q3W (Part 1)	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	0	8	0	4	2	4	1	2	1	8
Median (95% Confidence Interval) [month]	3.0	1.4	5.3	5.8	NA	2.8	NA	1.4

30. Secondary Outcome

Title	Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2)
Time Frame	Baseline up to 24 months

Outcome Measure Data

Analysis Population Description

OS was not estimable since there were fewer number of participants with event.

Arm/Group Title	PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Measure Participants	0

Adverse Events

Time Frame	Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title	PF-06647263 0.01 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg Q3W (Part 1)		PF-06647263 0.02 mg/kg QW (Part 1)		PF-06647263 0.03 mg/kg Q3W (Part 1)		PF-06647263 0.05 mg/kg Q3W (Part 1)		PF-06647263 0.075 mg/kg Q3W (Part 1)		PF-06647263 0.1 mg/kg Q3W (Part 1)		PF-06647263 0.134 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 2)
Arm/Group Description	Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.		Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
All Cause Mortality
	PF-06647263 0.01 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg Q3W (Part 1)		PF-06647263 0.02 mg/kg QW (Part 1)		PF-06647263 0.03 mg/kg Q3W (Part 1)		PF-06647263 0.05 mg/kg Q3W (Part 1)		PF-06647263 0.075 mg/kg Q3W (Part 1)		PF-06647263 0.1 mg/kg Q3W (Part 1)		PF-06647263 0.134 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 2)
	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	0/3 (0%)		4/13 (30.8%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Serious Adverse Events
	PF-06647263 0.01 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg Q3W (Part 1)		PF-06647263 0.02 mg/kg QW (Part 1)		PF-06647263 0.03 mg/kg Q3W (Part 1)		PF-06647263 0.05 mg/kg Q3W (Part 1)		PF-06647263 0.075 mg/kg Q3W (Part 1)		PF-06647263 0.1 mg/kg Q3W (Part 1)		PF-06647263 0.134 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 2)
	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	1/3 (33.3%)		6/13 (46.2%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		1/9 (11.1%)		1/3 (33.3%)		3/6 (50%)		1/2 (50%)		4/12 (33.3%)
Cardiac disorders
Atrial fibrillation	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gastrointestinal disorders
Diarrhoea	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Gastric fistula	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Gastrointestinal haemorrhage	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nausea	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		2/12 (16.7%)
Oesophageal varices haemorrhage	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Small intestinal obstruction	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Upper gastrointestinal haemorrhage	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vomiting	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
General disorders
Death	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Disease progression	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Pyrexia	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Infections and infestations
Device related infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Sepsis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Urinary tract infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Influenza	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Fall	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Metabolism and nutrition disorders
Dehydration	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nervous system disorders
Paraesthesia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Pleural effusion	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	PF-06647263 0.01 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg Q3W (Part 1)		PF-06647263 0.02 mg/kg QW (Part 1)		PF-06647263 0.03 mg/kg Q3W (Part 1)		PF-06647263 0.05 mg/kg Q3W (Part 1)		PF-06647263 0.075 mg/kg Q3W (Part 1)		PF-06647263 0.1 mg/kg Q3W (Part 1)		PF-06647263 0.134 mg/kg QW (Part 1)		PF-06647263 0.015 mg/kg QW (Part 2)
	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	3/3 (100%)		13/13 (100%)		2/2 (100%)		7/7 (100%)		3/3 (100%)		9/9 (100%)		3/3 (100%)		6/6 (100%)		2/2 (100%)		12/12 (100%)
Blood and lymphatic system disorders
Anaemia	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		2/3 (66.7%)		0/9 (0%)		0/3 (0%)		2/6 (33.3%)		0/2 (0%)		1/12 (8.3%)
Leukocytosis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Leukopenia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Neutropenia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Splenic infarction	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Splenomegaly	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Thrombocytopenia	1/3 (33.3%)		4/13 (30.8%)		0/2 (0%)		3/7 (42.9%)		2/3 (66.7%)		3/9 (33.3%)		1/3 (33.3%)		3/6 (50%)		2/2 (100%)		3/12 (25%)
Cardiac disorders
Atrial fibrillation	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Palpitations	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Tachycardia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Ear and labyrinth disorders
Ear pain	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Endocrine disorders
Hypothyroidism	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Eye disorders
Conjunctival haemorrhage	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dry eye	1/3 (33.3%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Eye discharge	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Eye haemorrhage	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Eye irritation	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Eye pruritus	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Eye symptom	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Iritis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Lacrimation increased	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		2/3 (66.7%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
Mydriasis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Ocular hyperaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Vision blurred	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vitreous floaters	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Cataract	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Diplopia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Abdominal distension	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		3/6 (50%)		0/2 (0%)		0/12 (0%)
Abdominal pain	2/3 (66.7%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		2/3 (66.7%)		3/9 (33.3%)		1/3 (33.3%)		1/6 (16.7%)		2/2 (100%)		0/12 (0%)
Abdominal pain upper	1/3 (33.3%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Abdominal rigidity	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Abdominal tenderness	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Aphthous ulcer	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Ascites	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		2/2 (100%)		0/12 (0%)
Buccal mucosal roughening	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Constipation	1/3 (33.3%)		5/13 (38.5%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		3/9 (33.3%)		1/3 (33.3%)		1/6 (16.7%)		1/2 (50%)		3/12 (25%)
Diarrhoea	3/3 (100%)		2/13 (15.4%)		0/2 (0%)		4/7 (57.1%)		2/3 (66.7%)		2/9 (22.2%)		1/3 (33.3%)		2/6 (33.3%)		1/2 (50%)		3/12 (25%)
Dry mouth	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		2/9 (22.2%)		1/3 (33.3%)		2/6 (33.3%)		1/2 (50%)		2/12 (16.7%)
Dyspepsia	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		2/9 (22.2%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dysphagia	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		2/12 (16.7%)
Flatulence	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gastritis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gastrointestinal pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gastrooesophageal reflux disease	2/3 (66.7%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gingival bleeding	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gingival discolouration	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Gingival disorder	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Haematemesis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Haematochezia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Haemorrhoids	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Hypoaesthesia oral	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Large intestinal obstruction	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Mouth ulceration	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		2/9 (22.2%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nausea	2/3 (66.7%)		9/13 (69.2%)		2/2 (100%)		4/7 (57.1%)		3/3 (100%)		4/9 (44.4%)		3/3 (100%)		3/6 (50%)		2/2 (100%)		6/12 (50%)
Oral disorder	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Oral dysaesthesia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Oral pain	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Proctalgia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Proctitis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rectal haemorrhage	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Stomatitis	1/3 (33.3%)		0/13 (0%)		1/2 (50%)		0/7 (0%)		1/3 (33.3%)		3/9 (33.3%)		1/3 (33.3%)		0/6 (0%)		1/2 (50%)		1/12 (8.3%)
Tongue coated	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Tongue discolouration	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Tongue ulceration	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Vomiting	2/3 (66.7%)		7/13 (53.8%)		1/2 (50%)		4/7 (57.1%)		1/3 (33.3%)		2/9 (22.2%)		1/3 (33.3%)		2/6 (33.3%)		1/2 (50%)		6/12 (50%)
General disorders
Application site erosion	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Asthenia	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		4/12 (33.3%)
Catheter site erythema	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Catheter site pain	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Catheter site related reaction	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Chest discomfort	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Chills	1/3 (33.3%)		0/13 (0%)		1/2 (50%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Early satiety	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Face oedema	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Fatigue	2/3 (66.7%)		10/13 (76.9%)		1/2 (50%)		5/7 (71.4%)		2/3 (66.7%)		6/9 (66.7%)		3/3 (100%)		4/6 (66.7%)		2/2 (100%)		5/12 (41.7%)
Gait disturbance	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Generalised oedema	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Malaise	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Mucosal inflammation	1/3 (33.3%)		5/13 (38.5%)		0/2 (0%)		3/7 (42.9%)		1/3 (33.3%)		2/9 (22.2%)		1/3 (33.3%)		2/6 (33.3%)		1/2 (50%)		7/12 (58.3%)
Non-cardiac chest pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Oedema	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Oedema peripheral	0/3 (0%)		4/13 (30.8%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		1/9 (11.1%)		1/3 (33.3%)		3/6 (50%)		1/2 (50%)		3/12 (25%)
Pain	0/3 (0%)		0/13 (0%)		1/2 (50%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Pyrexia	2/3 (66.7%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		2/3 (66.7%)		1/9 (11.1%)		2/3 (66.7%)		0/6 (0%)		1/2 (50%)		2/12 (16.7%)
Temperature intolerance	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Axillary pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		2/12 (16.7%)
Feeling abnormal	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Localised oedema	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Hepatobiliary disorders
Hepatic congestion	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hepatic fibrosis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hepatic steatosis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Hyperbilirubinaemia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Venoocclusive liver disease	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Immune system disorders
Seasonal allergy	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Infections and infestations
Angular cheilitis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Asymptomatic bacteriuria	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Candida infection	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Clostridium difficile infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Conjunctivitis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
Device related infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Fungal infection	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Fungal skin infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Genital infection fungal	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Infected dermal cyst	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Infection	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Oral candidiasis	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		2/9 (22.2%)		2/3 (66.7%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Oral fungal infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pneumonia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		2/12 (16.7%)
Rash pustular	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rhinitis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Urinary tract infection	1/3 (33.3%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		1/3 (33.3%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Vaginal infection	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Bronchitis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Nail infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Upper respiratory tract infection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Burns second degree	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Contusion	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Fall	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Fracture	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Humerus fracture	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Radiation pneumonitis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Skin abrasion	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Wound	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Wound complication	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Investigations
Alanine aminotransferase increased	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Aspartate aminotransferase increased	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		2/7 (28.6%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Blood albumin decreased	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Blood alkaline phosphatase increased	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Blood bilirubin increased	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
Blood creatinine increased	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Breath sounds abnormal	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Cardiac murmur	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Electrocardiogram abnormal	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
International normalised ratio increased	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Neutrophil count decreased	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Peritoneal fluid analysis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Platelet count decreased	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Transaminases increased	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Weight decreased	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		2/9 (22.2%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		1/12 (8.3%)
Weight increased	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Metabolism and nutrition disorders
Decreased appetite	0/3 (0%)		6/13 (46.2%)		1/2 (50%)		4/7 (57.1%)		2/3 (66.7%)		4/9 (44.4%)		3/3 (100%)		4/6 (66.7%)		2/2 (100%)		5/12 (41.7%)
Dehydration	0/3 (0%)		4/13 (30.8%)		0/2 (0%)		1/7 (14.3%)		1/3 (33.3%)		2/9 (22.2%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Failure to thrive	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypercalcaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hyperglycaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hyperkalaemia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypoalbuminaemia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Hypocalcaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Hypokalaemia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		1/12 (8.3%)
Hypomagnesaemia	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		2/9 (22.2%)		2/3 (66.7%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Hyponatraemia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypophosphataemia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		2/12 (16.7%)
Iron deficiency	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Malnutrition	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Marasmus	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Ketoacidosis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Type 1 diabetes mellitus	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Back pain	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		2/9 (22.2%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		2/12 (16.7%)
Bone pain	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Musculoskeletal chest pain	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Musculoskeletal discomfort	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Musculoskeletal pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Myalgia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Pain in extremity	1/3 (33.3%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		3/12 (25%)
Pain in jaw	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Muscular weakness	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Squamous cell carcinoma of skin	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nervous system disorders
Ageusia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Cognitive disorder	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Depressed level of consciousness	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Disturbance in attention	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dizziness	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		2/6 (33.3%)		0/2 (0%)		1/12 (8.3%)
Dizziness postural	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dysgeusia	1/3 (33.3%)		6/13 (46.2%)		0/2 (0%)		2/7 (28.6%)		1/3 (33.3%)		1/9 (11.1%)		1/3 (33.3%)		4/6 (66.7%)		2/2 (100%)		1/12 (8.3%)
Encephalopathy	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Headache	1/3 (33.3%)		1/13 (7.7%)		2/2 (100%)		2/7 (28.6%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		2/12 (16.7%)
Memory impairment	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Neuralgia	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Neuropathy peripheral	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		1/6 (16.7%)		0/2 (0%)		1/12 (8.3%)
Parosmia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Presyncope	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Somnolence	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Tremor	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vocal cord paralysis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Migraine	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Psychiatric disorders
Agitation	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Anxiety	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		2/3 (66.7%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Confusional state	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Depression	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Insomnia	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Mental status changes	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Mood altered	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Renal and urinary disorders
Acute kidney injury	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Bladder pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Chronic kidney disease	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dysuria	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Haematuria	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Pollakiuria	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Proteinuria	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Urinary retention	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Reproductive system and breast disorders
Pelvic fluid collection	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Perineal pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Vaginal discharge	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vaginal haemorrhage	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vulvovaginal inflammation	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vulvovaginal pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Vulvovaginal pruritus	1/3 (33.3%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Vulvovaginal rash	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Bronchial obstruction	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Cough	1/3 (33.3%)		2/13 (15.4%)		1/2 (50%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Dry throat	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dyspnoea	0/3 (0%)		5/13 (38.5%)		0/2 (0%)		1/7 (14.3%)		1/3 (33.3%)		1/9 (11.1%)		2/3 (66.7%)		2/6 (33.3%)		1/2 (50%)		1/12 (8.3%)
Epistaxis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		2/2 (100%)		1/12 (8.3%)
Haemoptysis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Hiccups	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypoxia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Laryngeal pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nasal congestion	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nasal dryness	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Oropharyngeal pain	1/3 (33.3%)		2/13 (15.4%)		1/2 (50%)		0/7 (0%)		0/3 (0%)		2/9 (22.2%)		1/3 (33.3%)		0/6 (0%)		1/2 (50%)		1/12 (8.3%)
Pharyngeal erythema	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pleural effusion	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rhinitis allergic	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rhinorrhoea	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		2/9 (22.2%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Sinus congestion	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Tachypnoea	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Dysphonia	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Skin and subcutaneous tissue disorders
Alopecia	1/3 (33.3%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
Blister	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Dermatitis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Dermatitis acneiform	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Dermatitis bullous	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Dry skin	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		2/7 (28.6%)		0/3 (0%)		1/9 (11.1%)		2/3 (66.7%)		0/6 (0%)		0/2 (0%)		3/12 (25%)
Ecchymosis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Erythema	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Hyperkeratosis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Madarosis	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nail bed tenderness	0/3 (0%)		0/13 (0%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Nail discolouration	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Nail disorder	0/3 (0%)		3/13 (23.1%)		0/2 (0%)		1/7 (14.3%)		0/3 (0%)		2/9 (22.2%)		1/3 (33.3%)		2/6 (33.3%)		0/2 (0%)		0/12 (0%)
Night sweats	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Onychalgia	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Onycholysis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Onychomadesis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pain of skin	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Palmar-plantar erythrodysaesthesia syndrome	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Papule	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Petechiae	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Photosensitivity reaction	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pigmentation disorder	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pruritus	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		1/7 (14.3%)		1/3 (33.3%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		3/12 (25%)
Rash	1/3 (33.3%)		2/13 (15.4%)		1/2 (50%)		1/7 (14.3%)		1/3 (33.3%)		3/9 (33.3%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Rash erythematous	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rash generalised	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rash macular	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rash maculo-papular	1/3 (33.3%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		1/2 (50%)		0/12 (0%)
Rash papular	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Rash pruritic	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Scar pain	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		1/3 (33.3%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Skin discolouration	0/3 (0%)		2/13 (15.4%)		0/2 (0%)		2/7 (28.6%)		0/3 (0%)		2/9 (22.2%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Skin disorder	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Skin fragility	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		1/2 (50%)		0/12 (0%)
Skin hyperpigmentation	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		1/7 (14.3%)		1/3 (33.3%)		2/9 (22.2%)		1/3 (33.3%)		1/6 (16.7%)		2/2 (100%)		0/12 (0%)
Skin lesion	1/3 (33.3%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		2/12 (16.7%)
Telangiectasia	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Urticaria	1/3 (33.3%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		1/9 (11.1%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hair texture abnormal	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Surgical and medical procedures
Wound drainage	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)
Vascular disorders
Aortic stenosis	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		1/6 (16.7%)		0/2 (0%)		0/12 (0%)
Deep vein thrombosis	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Haemorrhage	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypertension	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		1/3 (33.3%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hypotension	1/3 (33.3%)		3/13 (23.1%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Pallor	0/3 (0%)		1/13 (7.7%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		0/12 (0%)
Hot flush	0/3 (0%)		0/13 (0%)		0/2 (0%)		0/7 (0%)		0/3 (0%)		0/9 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)		1/12 (8.3%)

Limitations/Caveats

The study was terminated due to sponsor's decision (for reasons other than safety) due to which data for few outcome measures was not analyzed and reported.

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Certain Agreements

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.