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A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01307267
Collaborator
(none)
190
Enrollment
42
Locations
2
Arms
92
Actual Duration (Months)
4.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 1 STUDY OF PF-05082566 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED CANCER, AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA (NHL)
Actual Study Start Date :
Jun 21, 2011
Actual Primary Completion Date :
Feb 20, 2019
Actual Study Completion Date :
Feb 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Portion A

PF-05082566 single agent in patients with advanced cancer

Drug: PF-05082566
Intravenous, Dose escalation, once per month
Experimental: Portion B

PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma

Drug: rituximab
Intravenous, 375 mg/m2, once per week for 4 weeks
Other Names:
  • Rituxan, MabThera

    • Drug: PF-05082566
    IV, Dose escalation, once per month

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A [Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)]

      DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.

    2. Number of Participants With DLTs in First 2 Cycles of Portion B [Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)]

      DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.

    Secondary Outcome Measures

    1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A [Up to approximately 2 years]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.

    2. Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A [Up to approximately 2 years]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).

    3. Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A [Up to approximately 2 years]

      Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.

    4. Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A [Up to approximately 2 years]

      Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.

    5. Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A [Up to approximately 2 years]

      For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator.

    6. PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose]

      Cmax of PF-05082566 was observed directly from data.

    7. PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A [Day 1 pre-dose of Cycle 2]

      Ctrough of PF-05082566 was observed directly from data.

    8. PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      Tmax of PF-05082566 was observed directly from data as time of Cmax.

    9. PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      AUClast of PF-05082566 was determined by linear/log trapezoidal method.

    10. PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.

    11. PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      AUCtau of PF-05082566 was determined using linear/log trapezoidal method.

    12. PF-05082566 Clearance (CL) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).

    13. PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A [Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.]

      Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.

    14. Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A [Up to approximately 2 years]

      ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23.

    15. Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A [Up to approximately 2 years]

      Categorical summarization criteria for QTc interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate): 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.

    16. Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Objective response: confirmed best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-progression of disease (non-PD), indeterminate or missing, and without 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 diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.

    17. Duration of Response in Portion A [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Duration of response: the time from first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1) to the date of first documentation of objective progression of disease (PD) or death due to any cause. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 millimeters (mm); or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions. This outcome measure reports the individual values for evaluable participants (instead of medians etc) due to the limited number of events.

    18. Time to Response in Portion A [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Time to response: the time from Cycle 1 Day 1 to the first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1). BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes decreased to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.

    19. Progression-Free Survival in Portion A [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Progression-free survival: the time from Cycle 1 Day 1 to the date of the first documentation of objective PD or death due to any cause, whichever occurred first. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm; or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions.

    20. Overall Survival in Portion A [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.

    21. Number of Participants With Treatment-Emergent AEs and SAEs in Portion B [Up to approximately 4 years]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.

    22. Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B [Up to approximately 4 years]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).

    23. Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B [Up to approximately 2 years]

      Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.

    24. Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B [Up to approximately 2 years]

      Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.

    25. Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B [Up to approximately 2 years]

      For vital signs in Portion B, blood pressure, pulse rate, and body temperature were measured. Clinical significance was determined by the investigator.

    26. PF-05082566 Cmax in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      Cmax of PF-05082566 was observed directly from data.

    27. PF-05082566 Ctrough in Portion B [Day 1 pre-dose of Cycle 2]

      Ctrough of PF-05082566 was observed directly from data.

    28. PF-05082566 Tmax in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      Tmax of PF-05082566 was observed directly from data as time of Cmax.

    29. PF-05082566 AUClast in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      AUClast of PF-05082566 was determined by linear/log trapezoidal method.

    30. PF-05082566 AUCinf in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose.]

      AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.

    31. PF-05082566 AUCtau in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      AUCtau of PF-05082566 was determined using linear/log trapezoidal method.

    32. PF-05082566 CL in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2.

    33. PF-05082566 Vss in Portion B [Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.]

      Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.

    34. Rituximab Cmax and Ctrough in Portion B [Day 1 pre-dose of Cycle 2]

      Cmax and Ctrough of rituximab were observed directly from data.

    35. Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B [Up to approximately 2 years]

      ADA for PF-05082566 and rituximab was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23. Positive ADA for rituximab: titer>=1.88.

    36. Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B [Up to approximately 2 years]

      Categorical summarization criteria for QTc interval: 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.

    37. Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Objective Response in Portion B was defined as BOR of CR or PR according to Cheson 2007 criteria. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the sum of the product diameters [SPD] of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in greatest transverse diameter [GTD], unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.

    38. Duration of Response in Portion B [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Duration of Response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from first documentation of objective response to the date of first documentation of objective PD or death due to any cause. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.

    39. Time to Response in Portion B [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Time to response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from Cycle 1 Day 1 to the first documentation of objective response. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the SPD of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.

    40. Progression-Free Survival in Portion B [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Progression-free survival in Portion B was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective PD (per Cheson 2007) or death due to any cause, whichever occurred first. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.

    41. Overall Survival in Portion B [Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)]

      Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.

    Other Outcome Measures

    1. Biomarkers Linked With Immunomodulation and Cytokine Release [Days 1, 14, 29 and 57]

      This was an exploratory endpoint and no data were collected.

    2. Exploratory Pharmacodynamic Biomarkers [Days 1 and 21]

      This was an exploratory endpoint and no data were collected.

    3. Patient-Reported Outcomes of PF-05082566 and Rituximab When Given in Combination in Follicular Lymphoma Participants [Up to 2 years]

      This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.

    Eligibility Criteria

    Criteria

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

    Inclusion Criteria

    • Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or B cell lymphoma, for which no curative therapy is available. Portion A expansion includes patients who have documented disease progression on a checkpoint inhibitor (anti CTLA 4, anti PD1/PD L1 antibodies) per RECIST criteria. Tumor types include metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NCSLC) and squamous cell carcinoma of the head and neck (SCCHN). Patients in the dose expansion stage are required to provide archival or baseline (obtained during the screening period) tumor biopsies.

    • Portion B: Histological confirmed relapsed or refractory CD20 positive NHL for which no curative therapy is available. Patients enrolled in the expansion cohort must have archival tissue available, sampled within 6 months of study entry. The Expansion cohort includes patients with FL or DLBCL with relapsed or refractory disease.

    • Measurable disease with at least one extranodal tumor mass >1.0 cm in the greatest transverse diameter (GTD) or in the case of malignant lymph nodes >1.5 cm in the GTD.

    • ECOG performance status of ≤ 1.

    • Adequate bone marrow function, for Portion A: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥100 x 109/L, hemoglobin >9.0 g/dL. For Portion B: ANC ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L, and hemoglobin ≥ 8.0 g/dL. In both cases, patients must be transfusion independent at least 14 days prior to screening.

    • Serum creatinine ≤ 2 x ULN or estimated creatinine clearance ≥ 50 ml/min.

    • Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome and AST and ALT ≤ 2.5 x ULN.

    Exclusion Criteria

    • Patients with known symptomatic brain metastases requiring steroids.

    • Prior allogeneic hematopoietic stem cell transplant.

    • Immunosuppressive regimens involving systemic corticosteroids within 14 days before the first dose of study treatment.

    • Therapeutic or experimental monoclonal antibodies within 28 day or prior radiation therapy within 14 days of the first dose of study drug.

    • Autoimmune disorders and other diseases that compromise or impair the immune system.

    • Unstable or serious concurrent medical conditions in the previous 6 months.

    • Prior therapy with any anti CD137 monoclonal antibody.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 UC San Diego Moores Cancer Center-Investigational Drug Services La Jolla California United States 92037-0845
    3 UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital) La Jolla California United States 92037
    4 UC San Diego Moores Cancer Center La Jolla California United States 92093
    5 Research Administration Office: Clinical Research Unit Los Angeles California United States 90095
    6 Ronald Reagan UCLA Medical Center, Drug Information Center Los Angeles California United States 90095
    7 UCLA Bowyer Clinic Los Angeles California United States 90095
    8 UCLA Hematology-Oncology Clinic Los Angeles California United States 90095
    9 Stanford University Medical Center Palo Alto California United States 94304
    10 Stanford University Medical Center Palo Alto California United States 94305
    11 UC San Diego Medical Center - Hillcrest San Diego California United States 92103
    12 Santa Monica UCLA Hematology & Oncology Clinic Santa Monica California United States 90404
    13 Stanford University Medical Center Stanford California United States 94305
    14 Georgetown University Medical Center Department of Pharmacy, Research Washington District of Columbia United States 20007
    15 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    16 Emory University Hospital Midtown Atlanta Georgia United States 30308
    17 Emory University Hospital Atlanta Georgia United States 30322
    18 The Emory Clinic, Building A Atlanta Georgia United States 30322
    19 The Emory Clinic Atlanta Georgia United States 30322
    20 Winship Cancer Institute Atlanta Georgia United States 30322
    21 Brigham and Woman's Hospital Boston Massachusetts United States 02115
    22 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    23 University of Michigan Health System Ann Arbor Michigan United States 48109
    24 Siteman Cancer Center-West County Creve Coeur Missouri United States 63141
    25 Barnes-Jewish Hospital Saint Louis Missouri United States 63110-1094
    26 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    27 Washington University Infusion Center Pharmacy Saint Louis Missouri United States 63110
    28 Washington University School of Medicine Saint Louis Missouri United States 63110
    29 Siteman Cancer Center- South County Saint Louis Missouri United States 63129
    30 Siteman Cancer Center - St. Peters Saint Peters Missouri United States 63376
    31 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    32 The University of Texas - M.D. Anderson Cancer Center Houston Texas United States 77030
    33 South Texas Accelerated Research Therapeutics, LLC San Antonio Texas United States 78229
    34 Seattle Cancer Care Alliance Seattle Washington United States 98109
    35 University of Washington Medical Center Seattle Washington United States 98195
    36 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
    37 Centre d'investigation clinique RENNES cedex 9 France 35033
    38 Az. Ospedaliera-Univer. di Bologna Policlinico S. Orsola Malpighi Bologna BO Italy 40138
    39 Ospedale San Raffaele di Milano Milano MI Italy 20132
    40 National Cancer Center Hospital East Kashiwa Chiba Japan 277-8577
    41 Akita University Hospital Akita Japan 010-8543
    42 The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo Japan 135-8550

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01307267
    Other Study ID Numbers:
    • B1641001
    • 2011-002799-17
    First Posted:
    Mar 2, 2011
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Phase 1
    Non-Hodgkin's Lymphoma
    Advanced malignancies
    Additional relevant MeSH terms:
    Lymphoma
    Carcinoma
    Melanoma
    Carcinoma, Non-Small-Cell Lung
    Lymphoma, Non-Hodgkin
    Carcinoma, Renal Cell
    Carcinoma, Squamous Cell
    Lymphoma, Large B-Cell, Diffuse
    Lymphoma, Follicular
    Squamous Cell Carcinoma of Head and Neck
    Rituximab
    Antibodies, Monoclonal
    Immunoglobulin G

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail There was 1 participant who was enrolled but withdrew the consent before starting any of the treatment arms; therefore, this participant was not included in the participant flow table.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Period Title: Overall Study
    STARTED 4 3 6 4 3 42 3 4 31 5 6 11 3 3 4 3 3 3 4 32 3 5 4
    COMPLETED 0 0 1 1 2 1 1 0 1 0 0 0 2 3 2 2 2 2 2 0 0 0 0
    NOT COMPLETED 4 3 5 3 1 41 2 4 30 5 6 11 1 0 2 1 1 1 2 32 3 5 4

    Baseline Characteristics

    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2 Total
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Total of all reporting groups
    Overall Participants 4 3 6 4 3 42 3 4 31 5 6 11 3 3 4 3 3 3 4 32 3 5 4 189
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    75%
    2
    66.7%
    4
    66.7%
    3
    75%
    1
    33.3%
    17
    40.5%
    1
    33.3%
    2
    50%
    19
    61.3%
    4
    80%
    3
    50%
    5
    45.5%
    3
    100%
    2
    66.7%
    4
    100%
    0
    0%
    2
    66.7%
    3
    100%
    2
    50%
    14
    43.8%
    0
    0%
    3
    60%
    3
    75%
    100
    52.9%
    >=65 years
    1
    25%
    1
    33.3%
    2
    33.3%
    1
    25%
    2
    66.7%
    25
    59.5%
    2
    66.7%
    2
    50%
    12
    38.7%
    1
    20%
    3
    50%
    6
    54.5%
    0
    0%
    1
    33.3%
    0
    0%
    3
    100%
    1
    33.3%
    0
    0%
    2
    50%
    18
    56.3%
    3
    100%
    2
    40%
    1
    25%
    89
    47.1%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    33.3%
    2
    33.3%
    2
    50%
    2
    66.7%
    15
    35.7%
    0
    0%
    1
    25%
    13
    41.9%
    3
    60%
    1
    16.7%
    3
    27.3%
    2
    66.7%
    1
    33.3%
    2
    50%
    1
    33.3%
    2
    66.7%
    1
    33.3%
    1
    25%
    15
    46.9%
    1
    33.3%
    2
    40%
    1
    25%
    72
    38.1%
    Male
    4
    100%
    2
    66.7%
    4
    66.7%
    2
    50%
    1
    33.3%
    27
    64.3%
    3
    100%
    3
    75%
    18
    58.1%
    2
    40%
    5
    83.3%
    8
    72.7%
    1
    33.3%
    2
    66.7%
    2
    50%
    2
    66.7%
    1
    33.3%
    2
    66.7%
    3
    75%
    17
    53.1%
    2
    66.7%
    3
    60%
    3
    75%
    117
    61.9%
    Race/Ethnicity, Customized (Count of Participants)
    White
    3
    75%
    3
    100%
    3
    50%
    4
    100%
    2
    66.7%
    36
    85.7%
    1
    33.3%
    4
    100%
    24
    77.4%
    4
    80%
    2
    33.3%
    4
    36.4%
    2
    66.7%
    3
    100%
    3
    75%
    2
    66.7%
    2
    66.7%
    2
    66.7%
    4
    100%
    22
    68.8%
    2
    66.7%
    5
    100%
    4
    100%
    141
    74.6%
    Black
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    1
    2.4%
    1
    33.3%
    0
    0%
    1
    3.2%
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    7
    3.7%
    Asian
    1
    25%
    0
    0%
    2
    33.3%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    2
    6.5%
    0
    0%
    3
    50%
    7
    63.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6
    18.8%
    0
    0%
    0
    0%
    0
    0%
    22
    11.6%
    Other
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    4
    9.5%
    0
    0%
    0
    0%
    4
    12.9%
    0
    0%
    1
    16.7%
    0
    0%
    1
    33.3%
    0
    0%
    1
    25%
    1
    33.3%
    1
    33.3%
    0
    0%
    0
    0%
    4
    12.5%
    0
    0%
    0
    0%
    0
    0%
    18
    9.5%
    Unspecified
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
    Description DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
    Time Frame Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 31 5 6 11
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Number of Participants With DLTs in First 2 Cycles of Portion B
    Description DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
    Time Frame Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 and 1 dose of rituximab in the first 2 cycles of Portion B.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 31 3 5 4
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 31 5 6 11
    AEs
    3
    75%
    3
    100%
    5
    83.3%
    4
    100%
    3
    100%
    39
    92.9%
    3
    100%
    4
    100%
    26
    83.9%
    5
    100%
    5
    83.3%
    9
    81.8%
    SAEs
    0
    0%
    0
    0%
    2
    33.3%
    1
    25%
    0
    0%
    13
    31%
    0
    0%
    0
    0%
    8
    25.8%
    1
    20%
    2
    33.3%
    3
    27.3%
    AEs related to PF-05082566
    2
    50%
    1
    33.3%
    2
    33.3%
    1
    25%
    2
    66.7%
    25
    59.5%
    1
    33.3%
    1
    25%
    10
    32.3%
    1
    20%
    2
    33.3%
    4
    36.4%
    SAEs related to PF-05082566
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    9.5%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 31 5 6 11
    Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    1
    25%
    1
    33.3%
    9
    21.4%
    2
    66.7%
    1
    25%
    7
    22.6%
    1
    20%
    1
    16.7%
    2
    18.2%
    Grade 2
    1
    25%
    2
    66.7%
    2
    33.3%
    1
    25%
    0
    0%
    14
    33.3%
    1
    33.3%
    2
    50%
    8
    25.8%
    3
    60%
    2
    33.3%
    4
    36.4%
    Grade 3
    2
    50%
    1
    33.3%
    2
    33.3%
    2
    50%
    2
    66.7%
    12
    28.6%
    0
    0%
    1
    25%
    9
    29%
    1
    20%
    2
    33.3%
    2
    18.2%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    4.8%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    4.8%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    1
    9.1%
    5. Secondary Outcome
    Title Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
    Description Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 28 4 6 11
    Anemia, Grade 1
    1
    25%
    3
    100%
    3
    50%
    3
    75%
    1
    33.3%
    20
    47.6%
    2
    66.7%
    1
    25%
    12
    38.7%
    1
    20%
    3
    50%
    6
    54.5%
    Anemia, Grade 2
    2
    50%
    0
    0%
    3
    50%
    1
    25%
    1
    33.3%
    6
    14.3%
    0
    0%
    2
    50%
    8
    25.8%
    0
    0%
    2
    33.3%
    5
    45.5%
    Anemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    Lymphocyte count increased, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    Lymphopenia, Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    7
    16.7%
    0
    0%
    1
    25%
    4
    12.9%
    1
    20%
    0
    0%
    6
    54.5%
    Lymphopenia, Grade 2
    3
    75%
    0
    0%
    2
    33.3%
    0
    0%
    2
    66.7%
    10
    23.8%
    1
    33.3%
    1
    25%
    6
    19.4%
    1
    20%
    3
    50%
    2
    18.2%
    Lymphopenia, Grade 3
    1
    25%
    1
    33.3%
    1
    16.7%
    3
    75%
    1
    33.3%
    7
    16.7%
    1
    33.3%
    1
    25%
    2
    6.5%
    1
    20%
    1
    16.7%
    0
    0%
    Lymphopenia, Grade 4
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (absolute), Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    1
    16.7%
    1
    9.1%
    Neutrophils (absolute), Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (absolute), Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Platelets, Grade 1
    2
    50%
    2
    66.7%
    2
    33.3%
    1
    25%
    2
    66.7%
    7
    16.7%
    1
    33.3%
    2
    50%
    2
    6.5%
    1
    20%
    1
    16.7%
    1
    9.1%
    White blood cells, Grade 1
    1
    25%
    1
    33.3%
    1
    16.7%
    2
    50%
    0
    0%
    4
    9.5%
    1
    33.3%
    2
    50%
    6
    19.4%
    0
    0%
    2
    33.3%
    3
    27.3%
    White blood cells, Grade 2
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White blood cells, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    6. Secondary Outcome
    Title Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
    Description Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    "Number of Participants Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had chemistries laboratory test data. "Number Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had data for the specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 28 4 6 11
    ALT, Grade 1
    1
    25%
    1
    33.3%
    1
    16.7%
    1
    25%
    0
    0%
    1
    2.4%
    0
    0%
    1
    25%
    6
    19.4%
    0
    0%
    0
    0%
    1
    9.1%
    ALT, Grade 2
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    Alkaline phosphatase, Grade 1
    2
    50%
    0
    0%
    1
    16.7%
    0
    0%
    2
    66.7%
    13
    31%
    0
    0%
    0
    0%
    6
    19.4%
    1
    20%
    3
    50%
    4
    36.4%
    Alkaline phosphatase, Grade 2
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    3
    7.1%
    1
    33.3%
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    0
    0%
    Alkaline phosphatase, Grade 3
    0
    0%
    1
    33.3%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, Grade 1
    3
    75%
    2
    66.7%
    1
    16.7%
    1
    25%
    2
    66.7%
    12
    28.6%
    2
    66.7%
    2
    50%
    7
    22.6%
    1
    20%
    2
    33.3%
    1
    9.1%
    AST, Grade 2
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Bilirubin (total), Grade 1
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    3
    7.1%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    Bilirubin (total), Grade 2
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    3
    7.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Creatinine, Grade 1
    3
    75%
    3
    100%
    5
    83.3%
    4
    100%
    3
    100%
    22
    52.4%
    2
    66.7%
    2
    50%
    19
    61.3%
    4
    80%
    5
    83.3%
    6
    54.5%
    Creatinine, Grade 2
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    4.8%
    0
    0%
    1
    25%
    1
    3.2%
    0
    0%
    0
    0%
    1
    9.1%
    GGT, Grade 2
    1
    25%
    0
    0%
    1
    16.7%
    GGT, Grade 3
    1
    25%
    2
    66.7%
    1
    16.7%
    Hypercalcemia, Grade 1
    1
    25%
    1
    33.3%
    0
    0%
    0
    0%
    1
    33.3%
    3
    7.1%
    0
    0%
    0
    0%
    1
    3.2%
    1
    20%
    0
    0%
    0
    0%
    Hyperglycemia, Grade 1
    2
    50%
    0
    0%
    3
    50%
    3
    75%
    3
    100%
    20
    47.6%
    3
    100%
    3
    75%
    13
    41.9%
    2
    40%
    4
    66.7%
    6
    54.5%
    Hyperglycemia, Grade 2
    2
    50%
    2
    66.7%
    2
    33.3%
    0
    0%
    0
    0%
    7
    16.7%
    0
    0%
    1
    25%
    3
    9.7%
    1
    20%
    1
    16.7%
    3
    27.3%
    Hyperglycemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    0
    0%
    Hyperkalemia, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    2
    4.8%
    0
    0%
    0
    0%
    3
    9.7%
    1
    20%
    0
    0%
    0
    0%
    Hyperkalemia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypermagnesemia, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    1
    33.3%
    3
    7.1%
    1
    33.3%
    1
    25%
    3
    9.7%
    0
    0%
    1
    16.7%
    0
    0%
    Hypermagnesemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypernatremia, Grade 1
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    Hypoalbuminemia, Grade 1
    1
    25%
    1
    33.3%
    4
    66.7%
    4
    100%
    1
    33.3%
    18
    42.9%
    1
    33.3%
    3
    75%
    9
    29%
    2
    40%
    2
    33.3%
    4
    36.4%
    Hypoalbuminemia, Grade 2
    2
    50%
    1
    33.3%
    2
    33.3%
    0
    0%
    1
    33.3%
    1
    2.4%
    0
    0%
    0
    0%
    3
    9.7%
    0
    0%
    1
    16.7%
    4
    36.4%
    Hypoalbuminemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypocalcemia, Grade 1
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    7
    16.7%
    0
    0%
    1
    25%
    5
    16.1%
    0
    0%
    3
    50%
    0
    0%
    Hypocalcemia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypocalcemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypoglycemia, Grade 1
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypoglycemia, Grade 2
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypokalemia, Grade 1
    1
    25%
    0
    0%
    2
    33.3%
    1
    25%
    1
    33.3%
    4
    9.5%
    2
    66.7%
    1
    25%
    3
    9.7%
    1
    20%
    0
    0%
    2
    18.2%
    Hypokalemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    1
    16.7%
    0
    0%
    Hypokalemia, Grade 4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypomagnesemia, Grade 1
    2
    50%
    1
    33.3%
    1
    16.7%
    2
    50%
    0
    0%
    8
    19%
    0
    0%
    1
    25%
    3
    9.7%
    1
    20%
    1
    16.7%
    0
    0%
    Hyponatremia, Grade 1
    2
    50%
    2
    66.7%
    2
    33.3%
    1
    25%
    0
    0%
    17
    40.5%
    2
    66.7%
    0
    0%
    8
    25.8%
    4
    80%
    1
    16.7%
    2
    18.2%
    Hyponatremia, Grade 3
    1
    25%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    1
    2.4%
    0
    0%
    1
    25%
    1
    3.2%
    0
    0%
    2
    33.3%
    0
    0%
    Hypophosphatemia, Grade 2
    0
    0%
    2
    66.7%
    0
    0%
    2
    50%
    0
    0%
    8
    19%
    2
    66.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    27.3%
    Hypophosphatemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    2.4%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    1
    16.7%
    0
    0%
    7. Secondary Outcome
    Title Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A
    Description For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 31 5 6 11
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A
    Description Cmax of PF-05082566 was observed directly from data.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    0.1515
    (12)
    0.4952
    (34)
    1.014
    (24)
    2.614
    (23)
    4.219
    (16)
    3.246
    (30)
    7.038
    (23)
    11.72
    (28)
    18.02
    (24)
    49.63
    (24)
    97.75
    (13)
    150.3
    (24)
    Cycle 2
    0.1250
    (NA)
    0.5049
    (7)
    1.093
    (47)
    3.408
    (25)
    4.013
    (25)
    2.955
    (46)
    8.349
    (NA)
    14.80
    (24)
    17.61
    (36)
    58.38
    (33)
    101.6
    (17)
    167.0
    (21)
    9. Secondary Outcome
    Title PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A
    Description Ctrough of PF-05082566 was observed directly from data.
    Time Frame Day 1 pre-dose of Cycle 2

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 2 3 6 3 3 37 2 4 24 3 5 10
    Geometric Mean (Geometric Coefficient of Variation) [μg/mL]
    NA
    (NA)
    0.1063
    (24)
    0.1092
    (24)
    0.3268
    (12)
    0.4285
    (49)
    0.3868
    (46)
    0.8597
    (NA)
    1.520
    (22)
    1.313
    (61)
    7.054
    (52)
    9.934
    (35)
    9.963
    (250)
    10. Secondary Outcome
    Title PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A
    Description Tmax of PF-05082566 was observed directly from data as time of Cmax.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    1.75
    1.63
    2.00
    1.26
    1.25
    1.03
    1.00
    1.80
    1.17
    1.50
    1.06
    1.50
    Cycle 2
    13.0
    1.50
    1.54
    1.00
    2.00
    1.03
    1.00
    1.46
    1.02
    1.08
    1.92
    1.31
    11. Secondary Outcome
    Title PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A
    Description AUClast of PF-05082566 was determined by linear/log trapezoidal method.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    8.212
    (251)
    101.0
    (9)
    148.1
    (33)
    389.4
    (58)
    703.3
    (32)
    481.1
    (48)
    996.1
    (29)
    2165
    (21)
    2383
    (61)
    5731
    (101)
    15540
    (22)
    25520
    (24)
    Cycle 2
    14.21
    (NA)
    105.2
    (49)
    93.59
    (152)
    614.9
    (7)
    808.0
    (53)
    818.7
    (38)
    1662
    (NA)
    1918
    (40)
    4035
    (25)
    6741
    (6)
    18140
    (24)
    19900
    (51)
    12. Secondary Outcome
    Title PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A
    Description AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    120
    (NA)
    187.5
    (31)
    667.0
    (13)
    989.5
    (NA)
    687.9
    (43)
    770.0
    (NA)
    2916
    (NA)
    3111
    (36)
    7628
    (NA)
    18430
    (24)
    28280
    (28)
    Cycle 2
    169.8
    (NA)
    251.4
    (17)
    931.0
    (NA)
    1072
    (57)
    960.8
    (47)
    2000
    (NA)
    1782
    (NA)
    4649
    (25)
    8480
    (NA)
    20950
    (23)
    22400
    (26)
    13. Secondary Outcome
    Title PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A
    Description AUCtau of PF-05082566 was determined using linear/log trapezoidal method.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    13.70
    (181)
    104.8
    (9)
    154.2
    (27)
    503.9
    (14)
    690.9
    (33)
    538.6
    (33)
    1012
    (27)
    2195
    (21)
    2761
    (34)
    8204
    (36)
    15760
    (20)
    25250
    (23)
    Cycle 2
    130.8
    (NA)
    224.4
    (19)
    618.6
    (NA)
    864.1
    (47)
    824.3
    (37)
    1681
    (NA)
    2107
    (43)
    4068
    (27)
    7460
    (NA)
    19040
    (18)
    20490
    (17)
    14. Secondary Outcome
    Title PF-05082566 Clearance (CL) in Portion A
    Description CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    0.2510
    (NA)
    0.3203
    (31)
    0.1800
    (13)
    0.1823
    (NA)
    0.3490
    (42)
    0.3890
    (NA)
    0.2054
    (NA)
    0.3861
    (36)
    0.3145
    (NA)
    0.2711
    (24)
    0.3536
    (28)
    Cycle 2
    0.2296
    (NA)
    0.2676
    (19)
    0.1939
    (NA)
    0.2082
    (47)
    0.2906
    (37)
    0.1786
    (NA)
    0.2847
    (43)
    0.2950
    (27)
    0.3220
    (NA)
    0.2626
    (18)
    0.4883
    (17)
    15. Secondary Outcome
    Title PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A
    Description Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
    Time Frame Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    Cycle 1
    65.50
    (NA)
    101.1
    (20)
    83.63
    (15)
    74.38
    (NA)
    110.7
    (28)
    75.20
    (NA)
    82.38
    (NA)
    112.2
    (29)
    110.4
    (NA)
    97.07
    (26)
    125.5
    (21)
    Cycle 2
    102.1
    (NA)
    74.11
    (21)
    90.80
    (NA)
    81.69
    (27)
    86.50
    (29)
    51.00
    (NA)
    61.54
    (NA)
    116.5
    (62)
    99.80
    (NA)
    87.37
    (43)
    139.5
    (29)
    16. Secondary Outcome
    Title Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A
    Description ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and was tested for ADA.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 42 3 4 31 5 6 11
    Count of Participants [Participants]
    4
    100%
    2
    66.7%
    5
    83.3%
    0
    0%
    0
    0%
    20
    47.6%
    1
    33.3%
    3
    75%
    14
    45.2%
    1
    20%
    3
    50%
    2
    18.2%
    17. Secondary Outcome
    Title Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
    Description Categorical summarization criteria for QTc interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate): 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had post-baseline QTc data. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 3 40 3 4 29 5 6 11
    QTc >450 to <=480 msec
    1
    25%
    0
    0%
    0
    0%
    2
    50%
    0
    0%
    10
    23.8%
    0
    0%
    1
    25%
    8
    25.8%
    2
    40%
    3
    50%
    4
    36.4%
    QTc >480 to <=500 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    4.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    QTc >500 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    0
    0%
    QTc change >30 to <=60 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    6
    14.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    33.3%
    3
    27.3%
    QTc change >60 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    18. Secondary Outcome
    Title Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A
    Description Objective response: confirmed best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-progression of disease (non-PD), indeterminate or missing, and without 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 diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 1 42 3 4 31 5 6 11
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4.8
    11.4%
    0
    0%
    25.0
    625%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    19. Secondary Outcome
    Title Duration of Response in Portion A
    Description Duration of response: the time from first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1) to the date of first documentation of objective progression of disease (PD) or death due to any cause. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 millimeters (mm); or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions. This outcome measure reports the individual values for evaluable participants (instead of medians etc) due to the limited number of events.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and achieved an objective response. "Number analyzed" represents the number of such participants for each specified category.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 2 0 1 0 0 0 0
    For Participant X in 0.24 mg/kg
    5.8
    For Participant Y in 0.24 mg/kg
    24.2
    For Participant Z in 0.6 mg/kg
    22.8
    20. Secondary Outcome
    Title Time to Response in Portion A
    Description Time to response: the time from Cycle 1 Day 1 to the first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1). BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes decreased to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and and achieved an objective response.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 2 0 1 0 0 0 0
    Median (Full Range) [months]
    10.3
    1.8
    21. Secondary Outcome
    Title Progression-Free Survival in Portion A
    Description Progression-free survival: the time from Cycle 1 Day 1 to the date of the first documentation of objective PD or death due to any cause, whichever occurred first. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm; or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 1 42 3 4 31 5 6 11
    Median (95% Confidence Interval) [months]
    1.7
    3.6
    1.7
    3.5
    1.7
    2.1
    1.6
    3.5
    1.7
    1.1
    3.3
    1.8
    22. Secondary Outcome
    Title Overall Survival in Portion A
    Description Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 4 3 6 4 1 42 3 4 31 5 6 11
    Median (95% Confidence Interval) [months]
    4.6
    4.0
    7.6
    13.3
    5.9
    9.0
    24.5
    NA
    7.6
    11.2
    29.5
    6.1
    23. Secondary Outcome
    Title Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.
    Time Frame Up to approximately 4 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 32 3 5 4
    AEs
    3
    75%
    3
    100%
    4
    66.7%
    3
    75%
    3
    100%
    3
    7.1%
    4
    133.3%
    30
    750%
    3
    9.7%
    4
    80%
    4
    66.7%
    SAEs
    1
    25%
    0
    0%
    0
    0%
    2
    50%
    1
    33.3%
    1
    2.4%
    1
    33.3%
    3
    75%
    0
    0%
    0
    0%
    0
    0%
    AEs related to PF-05082566
    2
    50%
    2
    66.7%
    2
    33.3%
    2
    50%
    1
    33.3%
    2
    4.8%
    3
    100%
    17
    425%
    2
    6.5%
    1
    20%
    1
    16.7%
    SAEs related to PF-05082566
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AEs related to rituximab
    3
    75%
    2
    66.7%
    3
    50%
    3
    75%
    2
    66.7%
    2
    4.8%
    3
    100%
    17
    425%
    2
    6.5%
    3
    60%
    3
    50%
    SAEs related to rituximab
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    24. Secondary Outcome
    Title Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).
    Time Frame Up to approximately 4 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 32 3 5 4
    Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    1
    33.3%
    1
    2.4%
    0
    0%
    7
    175%
    1
    3.2%
    3
    60%
    1
    16.7%
    Grade 2
    0
    0%
    2
    66.7%
    2
    33.3%
    0
    0%
    0
    0%
    2
    4.8%
    2
    66.7%
    17
    425%
    1
    3.2%
    1
    20%
    3
    50%
    Grade 3
    2
    50%
    1
    33.3%
    1
    16.7%
    3
    75%
    2
    66.7%
    0
    0%
    0
    0%
    5
    125%
    1
    3.2%
    0
    0%
    0
    0%
    Grade 4
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    25. Secondary Outcome
    Title Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
    Description Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had hematology laboratory test data.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 32 3 5 4
    Anemia, Grade 1
    3
    75%
    2
    66.7%
    2
    33.3%
    2
    50%
    1
    33.3%
    1
    2.4%
    2
    66.7%
    16
    400%
    0
    0%
    5
    100%
    1
    16.7%
    Anemia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    3
    75%
    2
    6.5%
    0
    0%
    0
    0%
    Hemoglobin increased, Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Lymphocyte count increased, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Lymphopenia, Grade 1
    1
    25%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    8
    200%
    0
    0%
    1
    20%
    1
    16.7%
    Lymphopenia, Grade 2
    1
    25%
    3
    100%
    3
    50%
    1
    25%
    0
    0%
    0
    0%
    1
    33.3%
    9
    225%
    2
    6.5%
    3
    60%
    0
    0%
    Lymphopenia, Grade 3
    1
    25%
    0
    0%
    0
    0%
    1
    25%
    1
    33.3%
    0
    0%
    1
    33.3%
    8
    200%
    0
    0%
    1
    20%
    2
    33.3%
    Neutrophils (absolute), Grade 1
    1
    25%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    1
    2.4%
    0
    0%
    2
    50%
    0
    0%
    1
    20%
    0
    0%
    Neutrophils (absolute), Grade 2
    1
    25%
    1
    33.3%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    100%
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (absolute), Grade 3
    1
    25%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (absolute), Grade 4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Platelets, Grade 1
    1
    25%
    1
    33.3%
    1
    16.7%
    2
    50%
    1
    33.3%
    0
    0%
    2
    66.7%
    11
    275%
    3
    9.7%
    1
    20%
    0
    0%
    Platelets, Grade 2
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Platelets, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    White blood cells, Grade 1
    1
    25%
    1
    33.3%
    2
    33.3%
    2
    50%
    0
    0%
    1
    2.4%
    1
    33.3%
    11
    275%
    1
    3.2%
    0
    0%
    0
    0%
    White blood cells, Grade 2
    1
    25%
    2
    66.7%
    1
    16.7%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    6
    150%
    0
    0%
    1
    20%
    0
    0%
    White blood cells, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    26. Secondary Outcome
    Title Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
    Description Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had chemistries laboratory test data.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 32 3 5 4
    ALT, Grade 1
    1
    25%
    2
    66.7%
    0
    0%
    1
    25%
    0
    0%
    1
    2.4%
    2
    66.7%
    7
    175%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Alkaline phosphatase, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    1
    25%
    0
    0%
    1
    2.4%
    2
    66.7%
    6
    150%
    1
    3.2%
    0
    0%
    0
    0%
    AST, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    1
    33.3%
    0
    0%
    2
    66.7%
    8
    200%
    1
    3.2%
    0
    0%
    0
    0%
    AST, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Bilirubin (total), Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    Bilirubin (total), Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    Creatinine, Grade 1
    2
    50%
    3
    100%
    4
    66.7%
    2
    50%
    3
    100%
    3
    7.1%
    2
    66.7%
    27
    675%
    3
    9.7%
    4
    80%
    4
    66.7%
    Creatinine, Grade 2
    1
    25%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    3
    75%
    0
    0%
    0
    0%
    0
    0%
    Hypercalcemia, Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.4%
    0
    0%
    0
    0%
    1
    3.2%
    0
    0%
    1
    16.7%
    Hyperglycemia, Grade 1
    2
    50%
    2
    66.7%
    3
    50%
    1
    25%
    2
    66.7%
    2
    4.8%
    2
    66.7%
    9
    225%
    1
    3.2%
    2
    40%
    0
    0%
    Hyperglycemia, Grade 2
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    7
    175%
    0
    0%
    1
    20%
    1
    16.7%
    Hyperglycemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    1
    16.7%
    Hyperkalemia, Grade 1
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    2
    50%
    1
    3.2%
    2
    40%
    1
    16.7%
    Hyperkalemia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Hyperkalemia, Grade 3
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypermagnesemia, Grade 1
    1
    25%
    1
    33.3%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    2
    66.7%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Hypermagnesemia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    Hypernatremia, Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Hypernatremia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Hypoalbuminemia, Grade 1
    0
    0%
    1
    33.3%
    0
    0%
    1
    25%
    1
    33.3%
    0
    0%
    1
    33.3%
    5
    125%
    1
    3.2%
    0
    0%
    0
    0%
    Hypoalbuminemia, Grade 2
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypocalcemia, Grade 1
    0
    0%
    2
    66.7%
    2
    33.3%
    2
    50%
    1
    33.3%
    0
    0%
    1
    33.3%
    10
    250%
    1
    3.2%
    1
    20%
    1
    16.7%
    Hypocalcemia, Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    Hypocalcemia, Grade 3
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypoglycemia, Grade 1
    1
    25%
    0
    0%
    1
    16.7%
    1
    25%
    0
    0%
    0
    0%
    1
    33.3%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    Hypoglycemia, Grade 3
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypokalemia, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    1
    25%
    0
    0%
    0
    0%
    1
    33.3%
    8
    200%
    1
    3.2%
    1
    20%
    0
    0%
    Hypomagnesemia, Grade 1
    0
    0%
    1
    33.3%
    0
    0%
    2
    50%
    1
    33.3%
    1
    2.4%
    1
    33.3%
    3
    75%
    0
    0%
    1
    20%
    1
    16.7%
    Hyponatremia, Grade 1
    0
    0%
    0
    0%
    1
    16.7%
    2
    50%
    1
    33.3%
    1
    2.4%
    0
    0%
    9
    225%
    2
    6.5%
    2
    40%
    1
    16.7%
    Hyponatremia, Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    Hypophosphatemia, Grade 2
    1
    25%
    0
    0%
    1
    16.7%
    1
    25%
    1
    33.3%
    1
    2.4%
    0
    0%
    8
    200%
    1
    3.2%
    1
    20%
    0
    0%
    Hypophosphatemia, Grade 3
    0
    0%
    0
    0%
    1
    16.7%
    1
    25%
    0
    0%
    0
    0%
    1
    33.3%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    27. Secondary Outcome
    Title Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B
    Description For vital signs in Portion B, blood pressure, pulse rate, and body temperature were measured. Clinical significance was determined by the investigator.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 32 3 5 4
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    28. Secondary Outcome
    Title PF-05082566 Cmax in Portion B
    Description Cmax of PF-05082566 was observed directly from data.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    0.6284
    (11)
    1.569
    (12)
    2.673
    (26)
    4.167
    (12)
    4.512
    (29)
    7.435
    (9)
    12.16
    (9)
    19.20
    (27)
    42.61
    (26)
    89.06
    (23)
    196.2
    (22)
    Cycle 2
    0.6838
    (18)
    1.948
    (6)
    3.102
    (18)
    3.934
    (28)
    4.607
    (30)
    6.481
    (10)
    13.97
    (24)
    20.03
    (32)
    44.35
    (19)
    95.16
    (19)
    206.0
    (29)
    29. Secondary Outcome
    Title PF-05082566 Ctrough in Portion B
    Description Ctrough of PF-05082566 was observed directly from data.
    Time Frame Day 1 pre-dose of Cycle 2

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had data for Ctrough.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 27 3 5 4
    Geometric Mean (Geometric Coefficient of Variation) [μg/mL]
    0.1267
    (47)
    0.2853
    (23)
    0.3922
    (29)
    0.4698
    (53)
    0.3539
    (110)
    0.6001
    (48)
    1.486
    (90)
    1.452
    (62)
    5.560
    (29)
    12.16
    (63)
    31.34
    (36)
    30. Secondary Outcome
    Title PF-05082566 Tmax in Portion B
    Description Tmax of PF-05082566 was observed directly from data as time of Cmax.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    1.50
    1.52
    1.06
    2.00
    1.52
    1.17
    2.00
    1.06
    2.00
    2.00
    2.00
    Cycle 2
    1.05
    1.08
    1.04
    1.57
    1.00
    1.50
    1.33
    1.02
    1.50
    1.50
    1.28
    31. Secondary Outcome
    Title PF-05082566 AUClast in Portion B
    Description AUClast of PF-05082566 was determined by linear/log trapezoidal method.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    121.1
    (26)
    342.6
    (13)
    513.7
    (20)
    854.1
    (31)
    701.7
    (72)
    1130
    (14)
    2373
    (37)
    2772
    (63)
    7955
    (30)
    17120
    (33)
    38180
    (18)
    Cycle 2
    176.2
    (26)
    471.5
    (7)
    696.5
    (17)
    1146
    (35)
    733.7
    (85)
    1511
    (10)
    3013
    (70)
    6193
    (22)
    10970
    (44)
    19410
    (37)
    48540
    (27)
    32. Secondary Outcome
    Title PF-05082566 AUCinf in Portion B
    Description AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had AUCinf data.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 2 1 2 3 3 3 1 23 2 2 2
    Geometric Mean (Geometric Coefficient of Variation) [μg*hr/mL]
    137.8
    (NA)
    407.0
    (NA)
    615.5
    (NA)
    1076
    (38)
    824.1
    (78)
    1421
    (24)
    2070
    (NA)
    3703
    (37)
    9439
    (NA)
    16790
    (NA)
    48870
    (NA)
    33. Secondary Outcome
    Title PF-05082566 AUCtau in Portion B
    Description AUCtau of PF-05082566 was determined using linear/log trapezoidal method.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    125.0
    (23)
    345.0
    (16)
    514.5
    (21)
    871.6
    (32)
    712.0
    (71)
    1128
    (15)
    2361
    (39)
    3206
    (32)
    8001
    (29)
    17290
    (32)
    38860
    (17)
    Cycle 2
    178.2
    (26)
    453.9
    (NA)
    701.8
    (18)
    1072
    (33)
    854.5
    (NA)
    1521
    (10)
    3116
    (63)
    5967
    (30)
    10220
    (30)
    18150
    (39)
    48030
    (16)
    34. Secondary Outcome
    Title PF-05082566 CL in Portion B
    Description CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    0.2178
    (NA)
    0.1470
    (NA)
    0.1950
    (NA)
    0.1667
    (38)
    0.2911
    (78)
    0.2107
    (24)
    0.2900
    (NA)
    0.3241
    (37)
    0.2546
    (NA)
    0.2973
    (NA)
    0.2048
    (NA)
    Cycle 2
    0.1683
    (26)
    0.1325
    (NA)
    0.1710
    (18)
    0.1681
    (33)
    0.2807
    (NA)
    0.1976
    (11)
    0.1928
    (63)
    0.2011
    (30)
    0.2351
    (29)
    0.2756
    (39)
    0.2080
    (16)
    35. Secondary Outcome
    Title PF-05082566 Vss in Portion B
    Description Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
    Time Frame Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 3 30 3 5 4
    Cycle 1
    81.87
    (NA)
    78.60
    (NA)
    79.93
    (NA)
    66.90
    (24)
    93.68
    (54)
    85.12
    (4)
    126.0
    (NA)
    102.8
    (20)
    130.9
    (NA)
    98.98
    (NA)
    94.08
    (NA)
    Cycle 2
    81.90
    (NA)
    65.42
    (NA)
    85.51
    (NA)
    66.27
    (NA)
    100.5
    (NA)
    86.99
    (NA)
    94.00
    (NA)
    102.2
    (NA)
    95.89
    (NA)
    36. Secondary Outcome
    Title Rituximab Cmax and Ctrough in Portion B
    Description Cmax and Ctrough of rituximab were observed directly from data.
    Time Frame Day 1 pre-dose of Cycle 2

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of rituximab in Portion B and had Cmax or Ctrough data for rituximab. No data were collected for this Outcome Measure.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 0 0 0 0 0 0
    37. Secondary Outcome
    Title Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B
    Description ADA for PF-05082566 and rituximab was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23. Positive ADA for rituximab: titer>=1.88.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and was tested for ADA. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 32 3 5 4
    For PF-05082566
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    For rituximab
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    38. Secondary Outcome
    Title Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
    Description Categorical summarization criteria for QTc interval: 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.
    Time Frame Up to approximately 2 years

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had post-baseline QTc data. "Number Analyzed" represents those participants who had data for each specified category.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 2 3 3 4 32 2 4 2
    QTc >450 to <=480 msec
    1
    25%
    0
    0%
    1
    16.7%
    0
    0%
    1
    33.3%
    1
    2.4%
    1
    33.3%
    14
    350%
    0
    0%
    2
    40%
    0
    0%
    QTc >480 to <=500 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    QTc >500 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    QTc change >30 to <=60 msec
    1
    25%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    200%
    0
    0%
    0
    0%
    0
    0%
    QTc change >60 msec
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    39. Secondary Outcome
    Title Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B
    Description Objective Response in Portion B was defined as BOR of CR or PR according to Cheson 2007 criteria. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the sum of the product diameters [SPD] of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in greatest transverse diameter [GTD], unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 31 3 5 4
    Number (95% Confidence Interval) [percentage of participants]
    33.3
    832.5%
    0
    0%
    25.0
    416.7%
    66.7
    1667.5%
    0
    0%
    0
    0%
    0
    0%
    25.8
    645%
    33.3
    107.4%
    20.0
    400%
    0
    0%
    40. Secondary Outcome
    Title Duration of Response in Portion B
    Description Duration of Response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from first documentation of objective response to the date of first documentation of objective PD or death due to any cause. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 1 0 1 2 0 0 0 8 1 1 0
    Median (95% Confidence Interval) [months]
    NA
    NA
    NA
    12.0
    9.5
    NA
    41. Secondary Outcome
    Title Time to Response in Portion B
    Description Time to response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from Cycle 1 Day 1 to the first documentation of objective response. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the SPD of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 1 0 1 2 0 0 0 8 1 1 0
    Median (Full Range) [months]
    2.1
    2.1
    2.0
    2.1
    3.9
    7.4
    42. Secondary Outcome
    Title Progression-Free Survival in Portion B
    Description Progression-free survival in Portion B was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective PD (per Cheson 2007) or death due to any cause, whichever occurred first. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 31 3 5 4
    Median (95% Confidence Interval) [months]
    NA
    8.1
    11.8
    9.9
    2.1
    5.7
    4.8
    3.9
    16.3
    3.9
    3.0
    43. Secondary Outcome
    Title Overall Survival in Portion B
    Description Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.
    Time Frame Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
    Arm/Group Title Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 3 3 4 3 3 3 4 31 3 5 4
    Median (95% Confidence Interval) [months]
    NA
    NA
    NA
    NA
    NA
    50.2
    NA
    NA
    NA
    NA
    NA
    44. Other Pre-specified Outcome
    Title Biomarkers Linked With Immunomodulation and Cytokine Release
    Description This was an exploratory endpoint and no data were collected.
    Time Frame Days 1, 14, 29 and 57

    Outcome Measure Data

    Analysis Population Description
    This was an exploratory endpoint and no data were collected.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    45. Other Pre-specified Outcome
    Title Exploratory Pharmacodynamic Biomarkers
    Description This was an exploratory endpoint and no data were collected.
    Time Frame Days 1 and 21

    Outcome Measure Data

    Analysis Population Description
    This was an exploratory endpoint and no data were collected.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    46. Other Pre-specified Outcome
    Title Patient-Reported Outcomes of PF-05082566 and Rituximab When Given in Combination in Follicular Lymphoma Participants
    Description This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    Measure Participants 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

    Adverse Events

    Time Frame Up to approximately 4 years.
    Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
    Arm/Group Title Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
    Arm/Group Description Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
    All Cause Mortality
    Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/4 (100%) 3/3 (100%) 5/6 (83.3%) 3/4 (75%) 1/3 (33.3%) 27/42 (64.3%) 2/3 (66.7%) 2/4 (50%) 21/31 (67.7%) 2/5 (40%) 3/6 (50%) 9/11 (81.8%) 0/3 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 2/4 (50%) 8/32 (25%) 1/3 (33.3%) 2/5 (40%) 2/4 (50%)
    Serious Adverse Events
    Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 2/6 (33.3%) 1/4 (25%) 0/3 (0%) 13/42 (31%) 0/3 (0%) 0/4 (0%) 8/31 (25.8%) 1/5 (20%) 2/6 (33.3%) 3/11 (27.3%) 1/3 (33.3%) 0/3 (0%) 0/4 (0%) 2/3 (66.7%) 1/3 (33.3%) 1/3 (33.3%) 1/4 (25%) 3/32 (9.4%) 0/3 (0%) 0/5 (0%) 0/4 (0%)
    Cardiac disorders
    Cardio-respiratory arrest 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 2 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Atrial fibrillation 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Ascites 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Colitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Constipation 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Enterocolitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Large intestinal haemorrhage 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Large intestinal obstruction 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nausea 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oesophageal obstruction 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Peritoneal haemorrhage 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Small intestinal obstruction 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Upper gastrointestinal haemorrhage 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Vomiting 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    General disorders
    Disease progression 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Fatigue 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pyrexia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hepatobiliary disorders
    Hyperbilirubinaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Infections and infestations
    Catheter site infection 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pneumonia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Sinusitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Urinary tract infection 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Cellulitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Cytomegalovirus chorioretinitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Upper respiratory tract infection 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Injury, poisoning and procedural complications
    Incisional hernia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Stress fracture 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Infusion related reaction 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Investigations
    Blood alkaline phosphatase increased 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dehydration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hyponatraemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intracranial tumour haemorrhage 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Malignant neoplasm progression 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nervous system disorders
    Dizziness 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 2 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pneumonitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pulmonary embolism 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Respiratory failure 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 2 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Aspiration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Idiopathic pulmonary fibrosis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Vascular disorders
    Thrombophlebitis superficial 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Other (Not Including Serious) Adverse Events
    Portion A: PF-05082566 0.006mg/kg Portion A: PF-05082566 0.03mg/kg Portion A: PF-05082566 0.06mg/kg Portion A: PF-05082566 0.12mg/kg Portion A: PF-05082566 0.18mg/kg Portion A: PF-05082566 0.24mg/kg Portion A: PF-05082566 0.3mg/kg Portion A: PF-05082566 0.6mg/kg Portion A: PF-05082566 1.2mg/kg Portion A: PF-05082566 2.4mg/kg Portion A: PF-05082566 5mg/kg Portion A: PF-05082566 10mg/kg Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/4 (75%) 3/3 (100%) 5/6 (83.3%) 4/4 (100%) 3/3 (100%) 36/42 (85.7%) 3/3 (100%) 4/4 (100%) 23/31 (74.2%) 4/5 (80%) 5/6 (83.3%) 9/11 (81.8%) 3/3 (100%) 3/3 (100%) 4/4 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 3/4 (75%) 29/32 (90.6%) 3/3 (100%) 4/5 (80%) 4/4 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 4/42 (9.5%) 6 0/3 (0%) 0 0/4 (0%) 0 5/31 (16.1%) 5 0/5 (0%) 0 2/6 (33.3%) 2 2/11 (18.2%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 2/3 (66.7%) 4 1/5 (20%) 1 0/4 (0%) 0
    Thrombocytopenia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Eosinophilia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Lymph node pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Neutropenia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 2 1/32 (3.1%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Cardiac disorders
    Palpitations 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 2 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Sinus tachycardia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Tachycardia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Ear and labyrinth disorders
    Deafness 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypoacusis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Tinnitus 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Ear pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Eye disorders
    Vision blurred 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Diplopia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Eye pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Orbital oedema 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Abdominal pain 1/4 (25%) 1 0/3 (0%) 0 1/6 (16.7%) 1 1/4 (25%) 1 1/3 (33.3%) 1 3/42 (7.1%) 3 1/3 (33.3%) 1 0/4 (0%) 0 5/31 (16.1%) 7 1/5 (20%) 1 1/6 (16.7%) 1 1/11 (9.1%) 2 2/3 (66.7%) 3 0/3 (0%) 0 0/4 (0%) 0 2/3 (66.7%) 3 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Abdominal pain lower 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Abdominal pain upper 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 3/42 (7.1%) 4 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Ascites 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Constipation 1/4 (25%) 1 0/3 (0%) 0 2/6 (33.3%) 2 0/4 (0%) 0 0/3 (0%) 0 2/42 (4.8%) 3 1/3 (33.3%) 1 0/4 (0%) 0 4/31 (12.9%) 4 1/5 (20%) 1 0/6 (0%) 0 2/11 (18.2%) 2 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Diarrhoea 1/4 (25%) 1 0/3 (0%) 0 2/6 (33.3%) 2 0/4 (0%) 0 1/3 (33.3%) 1 4/42 (9.5%) 5 0/3 (0%) 0 0/4 (0%) 0 6/31 (19.4%) 8 0/5 (0%) 0 0/6 (0%) 0 2/11 (18.2%) 3 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 1 4/32 (12.5%) 8 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Dry mouth 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 3 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Dyspepsia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 2/42 (4.8%) 2 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 3 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Haemorrhoids 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nausea 1/4 (25%) 1 0/3 (0%) 0 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 9/42 (21.4%) 10 0/3 (0%) 0 0/4 (0%) 0 10/31 (32.3%) 11 1/5 (20%) 1 1/6 (16.7%) 1 3/11 (27.3%) 5 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/4 (0%) 0 3/32 (9.4%) 4 1/3 (33.3%) 1 1/5 (20%) 2 0/4 (0%) 0
    Retching 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 1/3 (33.3%) 1 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Vomiting 2/4 (50%) 2 0/3 (0%) 0 2/6 (33.3%) 3 0/4 (0%) 0 1/3 (33.3%) 1 3/42 (7.1%) 4 0/3 (0%) 0 0/4 (0%) 0 4/31 (12.9%) 5 1/5 (20%) 1 1/6 (16.7%) 1 2/11 (18.2%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 1/5 (20%) 2 0/4 (0%) 0
    Diverticulum intestinal 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Dysphagia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Large intestine polyp 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Mouth ulceration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oral disorder 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Stomatitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Umbilical hernia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Abdominal tenderness 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    General disorders
    Axillary pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Chest pain 1/4 (25%) 1 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Chills 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 2/42 (4.8%) 2 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 2/5 (40%) 2 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/32 (3.1%) 3 1/3 (33.3%) 1 1/5 (20%) 1 0/4 (0%) 0
    Device related thrombosis 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Drug withdrawal syndrome 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Fatigue 1/4 (25%) 1 0/3 (0%) 0 2/6 (33.3%) 4 0/4 (0%) 0 1/3 (33.3%) 1 18/42 (42.9%) 19 0/3 (0%) 0 2/4 (50%) 2 8/31 (25.8%) 10 1/5 (20%) 1 0/6 (0%) 0 3/11 (27.3%) 3 2/3 (66.7%) 2 1/3 (33.3%) 1 0/4 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 3/4 (75%) 3 6/32 (18.8%) 7 0/3 (0%) 0 2/5 (40%) 3 1/4 (25%) 1
    Implant site erythema 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Influenza like illness 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 4 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Mucosal inflammation 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Non-cardiac chest pain 1/4 (25%) 2 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oedema peripheral 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 2/42 (4.8%) 2 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pain 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 3/31 (9.7%) 3 1/5 (20%) 1 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Peripheral swelling 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 2 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pyrexia 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 3 9/42 (21.4%) 11 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 1/6 (16.7%) 1 3/11 (27.3%) 3 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 2/3 (66.7%) 2 1/4 (25%) 1 5/32 (15.6%) 6 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Early satiety 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Infusion site oedema 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Feeling hot 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Ill-defined disorder 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Induration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Injection site pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Mucosal dryness 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nodule 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Hepatobiliary disorders
    Hyperbilirubinaemia 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hepatic steatosis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Infections and infestations
    Cellulitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oral candidiasis 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pneumonia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Upper respiratory tract infection 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 2/42 (4.8%) 4 0/3 (0%) 0 1/4 (25%) 2 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 2 2/3 (66.7%) 2 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/4 (0%) 0 4/32 (12.5%) 4 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Urinary tract infection 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 1/3 (33.3%) 1 2/42 (4.8%) 4 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 4 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Vaginal infection 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Bronchitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Conjunctivitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Diverticulitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Folliculitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Herpes zoster 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Influenza 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nasopharyngitis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oral herpes 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Tinea versicolour 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Injury, poisoning and procedural complications
    Eye injury 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Fall 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Skin abrasion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Wrist fracture 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Arthropod bite 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Back injury 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Contusion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Infusion related reaction 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 2 2/3 (66.7%) 2 1/3 (33.3%) 1 0/3 (0%) 0 2/4 (50%) 2 8/32 (25%) 10 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Procedural pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Scratch 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Investigations
    Alanine aminotransferase increased 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 3 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 1/3 (33.3%) 3 0/5 (0%) 0 0/4 (0%) 0
    Aspartate aminotransferase increased 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 4 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 3 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 1/3 (33.3%) 2 0/5 (0%) 0 0/4 (0%) 0
    Blood alkaline phosphatase increased 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Haemoglobin decreased 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Weight decreased 0/4 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 2 0/3 (0%) 0 1/4 (25%) 1 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 2/11 (18.2%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Activated partial thromboplastin time prolonged 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 1/3 (33.3%) 2 0/5 (0%) 0 0/4 (0%) 0
    Blood creatinine increased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 3 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 5/32 (15.6%) 5 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Electrocardiogram QT prolonged 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 8 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    International normalised ratio increased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 3 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Lymphocyte count decreased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 1/4 (25%) 1
    Neutrophil count decreased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 5 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Platelet count decreased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    White blood cell count decreased 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 2 1/32 (3.1%) 5 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/4 (25%) 1 1/3 (33.3%) 1 1/6 (16.7%) 1 0/4 (0%) 0 1/3 (33.3%) 1 4/42 (9.5%) 4 1/3 (33.3%) 1 0/4 (0%) 0 6/31 (19.4%) 7 1/5 (20%) 1 1/6 (16.7%) 1 2/11 (18.2%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dehydration 0/4 (0%) 0 1/3 (33.3%) 1 1/6 (16.7%) 1 0/4 (0%) 0 1/3 (33.3%) 1 2/42 (4.8%) 2 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Gout 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypokalaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 3/42 (7.1%) 5 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypomagnesaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 2 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hyponatraemia 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypophosphataemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 4 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypercalcaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 2 0/5 (0%) 0 0/4 (0%) 0
    Hyperglycaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 7 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hyperkalaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 3 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 2 0/5 (0%) 0 0/4 (0%) 0
    Hyperuricaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Hypoglycaemia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 3/42 (7.1%) 3 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 4/32 (12.5%) 5 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Back pain 1/4 (25%) 1 2/3 (66.7%) 2 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 5/42 (11.9%) 5 0/3 (0%) 0 2/4 (50%) 2 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 6/32 (18.8%) 8 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Bone pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Flank pain 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 2 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Groin pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 2 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Joint swelling 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Muscle spasms 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 2/5 (40%) 2 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Muscular weakness 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Musculoskeletal chest pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 3 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Musculoskeletal pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 2/42 (4.8%) 2 0/3 (0%) 0 1/4 (25%) 1 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Neck pain 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Pain in extremity 0/4 (0%) 0 2/3 (66.7%) 3 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 2/42 (4.8%) 2 0/3 (0%) 0 1/4 (25%) 1 2/31 (6.5%) 2 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Intervertebral disc degeneration 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Limb discomfort 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Muscle fatigue 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Myalgia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 2/4 (50%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 3/32 (9.4%) 3 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Neoplasm 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Squamous cell carcinoma 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Nervous system disorders
    Ataxia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Cognitive disorder 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dizziness 1/4 (25%) 1 1/3 (33.3%) 1 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 4/42 (9.5%) 5 1/3 (33.3%) 1 1/4 (25%) 3 3/31 (9.7%) 3 0/5 (0%) 0 1/6 (16.7%) 2 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/3 (66.7%) 2 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dysgeusia 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Headache 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 5/42 (11.9%) 6 0/3 (0%) 0 0/4 (0%) 0 2/31 (6.5%) 2 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 1/4 (25%) 1 3/32 (9.4%) 5 0/3 (0%) 0 2/5 (40%) 2 1/4 (25%) 1
    Hypoaesthesia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Lethargy 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Neuropathy peripheral 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Paraesthesia 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Peripheral sensory neuropathy 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Syncope 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Disturbance in attention 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Memory impairment 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Presyncope 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Psychiatric disorders
    Confusional state 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Delirium 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Insomnia 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 3/42 (7.1%) 3 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Anxiety 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Depression 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Sleep disorder 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Renal and urinary disorders
    Oliguria 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Urinary hesitation 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Pollakiuria 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Urine abnormality 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Reproductive system and breast disorders
    Vaginal haemorrhage 0/4 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Benign prostatic hyperplasia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Oedema genital 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Testicular pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 4/42 (9.5%) 5 0/3 (0%) 0 1/4 (25%) 1 2/31 (6.5%) 2 1/5 (20%) 1 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/3 (0%) 0 1/4 (25%) 1 7/32 (21.9%) 7 1/3 (33.3%) 1 0/5 (0%) 0 1/4 (25%) 1
    Dyspnoea 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 1/3 (33.3%) 1 6/42 (14.3%) 6 1/3 (33.3%) 1 1/4 (25%) 1 2/31 (6.5%) 2 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 1/3 (33.3%) 2 0/5 (0%) 0 1/4 (25%) 1
    Dyspnoea exertional 1/4 (25%) 2 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 2 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Hypoxia 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Increased upper airway secretion 0/4 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Sinus congestion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/31 (3.2%) 1 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 1/3 (33.3%) 1 1/5 (20%) 1 0/4 (0%) 0
    Bronchiectasis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Bronchospasm 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Nasal congestion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Oropharyngeal pain 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 3 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Oropharyngeal plaque 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Pleural effusion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/4 (25%) 1
    Productive cough 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Rhinorrhoea 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Throat irritation 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Upper-airway cough syndrome 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 2 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Erythema 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Pruritus 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/11 (9.1%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 3/32 (9.4%) 4 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Rash 1/4 (25%) 1 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 3/31 (9.7%) 3 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/32 (6.3%) 3 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Rash maculo-papular 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 3/42 (7.1%) 4 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Skin disorder 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Skin exfoliation 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Skin lesion 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 1/42 (2.4%) 1 0/3 (0%) 0 1/4 (25%) 1 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Urticaria 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Alopecia 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dermal cyst 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Dry skin 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/4 (0%) 0
    Hyperhidrosis 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 2/32 (6.3%) 3 1/3 (33.3%) 2 0/5 (0%) 0 0/4 (0%) 0
    Night sweats 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 3 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 1 2/32 (6.3%) 2 0/3 (0%) 0 1/5 (20%) 1 0/4 (0%) 0
    Rash papular 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Rash pruritic 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 4 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Seborrhoea 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Skin plaque 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Vascular disorders
    Hypertension 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/32 (3.1%) 1 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Lymphoedema 0/4 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/42 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/31 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/11 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/32 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    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.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01307267
    Other Study ID Numbers:
    • B1641001
    • 2011-002799-17
    First Posted:
    Mar 2, 2011
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    Mar 1, 2020