Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Squamous Cell of Head and Neck, Malignant Melanoma
Conditions
Keywords
Phase 1, Non-Hodgkin's Lymphoma, Advanced malignancies
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).
Interventions
DRUGPF-05082566
Intravenous, Dose escalation, once per month
DRUGrituximab
Intravenous, 375 mg/m2, once per week for 4 weeks
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| PF-05082566 Ctrough in Portion B | Day 1 pre-dose of Cycle 2 | Ctrough of PF-05082566 was observed directly from data. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Rituximab Cmax and Ctrough in Portion B | Day 1 pre-dose of Cycle 2 | Cmax and Ctrough of rituximab were observed directly from data. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers Linked With Immunomodulation and Cytokine Release | Days 1, 14, 29 and 57 | This was an exploratory endpoint and no data were collected. |
| Exploratory Pharmacodynamic Biomarkers | Days 1 and 21 | This was an exploratory endpoint and no data were collected. |
| 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. |
Countries
Australia, France, Italy, Japan, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Portion A: PF-05082566 0.006mg/kg 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. | 4 |
| Portion A: PF-05082566 0.03mg/kg 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. | 3 |
| Portion A: PF-05082566 0.06mg/kg 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. | 6 |
| Portion A: PF-05082566 0.12mg/kg 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. | 4 |
| Portion A: PF-05082566 0.18mg/kg 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. | 3 |
| Portion A: PF-05082566 0.24mg/kg 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. | 42 |
| Portion A: PF-05082566 0.3mg/kg 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. | 3 |
| Portion A: PF-05082566 0.6mg/kg 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. | 4 |
| Portion A: PF-05082566 1.2mg/kg 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. | 31 |
| Portion A: PF-05082566 2.4mg/kg 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. | 5 |
| Portion A: PF-05082566 5mg/kg 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. | 6 |
| Portion A: PF-05082566 10mg/kg 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. | 11 |
| Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 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. | 4 |
| Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 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. | 4 |
| Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 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. | 32 |
| Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 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. | 3 |
| Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 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. | 5 |
| Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2 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. | 4 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 4 | 3 | 5 | 3 | 1 | 26 | 2 | 2 | 21 | 2 | 3 | 9 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 8 | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 1 | 3 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 19 | 2 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 5 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | 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 0.006mg/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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 89 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 25 Participants | 2 Participants | 1 Participants | 2 Participants | 12 Participants | 1 Participants | 3 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 18 Participants | 3 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 2 Participants | 4 Participants | 3 Participants | 1 Participants | 17 Participants | 1 Participants | 3 Participants | 2 Participants | 19 Participants | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 14 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 22 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 7 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 18 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 141 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 36 Participants | 1 Participants | 3 Participants | 4 Participants | 24 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 22 Participants | 2 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 72 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 15 Participants | 0 Participants | 0 Participants | 1 Participants | 13 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 15 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 117 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 27 Participants | 3 Participants | 4 Participants | 3 Participants | 18 Participants | 2 Participants | 5 Participants | 8 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 17 Participants | 2 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 4 | 3 / 3 | 5 / 6 | 3 / 4 | 1 / 3 | 27 / 42 | 2 / 3 | 2 / 4 | 21 / 31 | 2 / 5 | 3 / 6 | 9 / 11 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 3 | 1 / 3 | 1 / 3 | 2 / 4 | 8 / 32 | 1 / 3 | 2 / 5 | 2 / 4 |
| other Total, other adverse events | 3 / 4 | 3 / 3 | 5 / 6 | 4 / 4 | 3 / 3 | 36 / 42 | 3 / 3 | 4 / 4 | 23 / 31 | 4 / 5 | 5 / 6 | 9 / 11 | 3 / 3 | 3 / 3 | 4 / 4 | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 4 | 29 / 32 | 3 / 3 | 4 / 5 | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 2 / 6 | 1 / 4 | 0 / 3 | 13 / 42 | 0 / 3 | 0 / 4 | 8 / 31 | 1 / 5 | 2 / 6 | 3 / 11 | 1 / 3 | 0 / 3 | 0 / 4 | 2 / 3 | 1 / 3 | 1 / 3 | 1 / 4 | 3 / 32 | 0 / 3 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Number of Participants With DLTs in First 2 Cycles of Portion B
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)
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With DLTs in First 2 Cycles of Portion B | 0 Participants |
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
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)
Population: All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | 0 Participants |
Secondary
Duration of Response in Portion A
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Portion A: PF-05082566 0.24mg/kg | Duration of Response in Portion A | For Participant X in 0.24 mg/kg | 5.8 months |
| Portion A: PF-05082566 0.24mg/kg | Duration of Response in Portion A | For Participant Y in 0.24 mg/kg | 24.2 months |
| Portion A: PF-05082566 0.6mg/kg | Duration of Response in Portion A | For Participant Z in 0.6 mg/kg | 22.8 months |
Secondary
Duration of Response in Portion B
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)
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Duration of Response in Portion B | NA months |
| Portion A: PF-05082566 0.06mg/kg | Duration of Response in Portion B | NA months |
| Portion A: PF-05082566 0.12mg/kg | Duration of Response in Portion B | NA months |
| Portion A: PF-05082566 0.6mg/kg | Duration of Response in Portion B | 12.0 months |
| Portion A: PF-05082566 1.2mg/kg | Duration of Response in Portion B | 9.5 months |
| Portion A: PF-05082566 2.4mg/kg | Duration of Response in Portion B | NA months |
Secondary
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 5 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | GGT, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 20 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 13 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 12 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 22 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 17 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 7 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 18 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 7 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 8 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 8 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 9 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 8 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 13 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 5 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 6 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 6 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 7 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 19 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 4 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 5 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypophosphatemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 1 | 6 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypokalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Hypoalbuminemia, Grade 2 | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Alkaline phosphatase, Grade 1 | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Creatinine, Grade 1 | 6 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | ALT, Grade 1 | 1 Participants |
Secondary
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 5 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 9 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 7 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 6 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 10 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 9 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 7 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 27 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 4 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Alkaline phosphatase, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 1 | 4 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypophosphatemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoglycemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyponatremia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypermagnesemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypercalcemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypocalcemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Creatinine, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypomagnesemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | ALT, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypoalbuminemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Bilirubin (total), Grade 2 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypokalemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperglycemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | AST, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hyperkalemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hypernatremia, Grade 1 | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A
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
Population: All participants who received at least 1 dose of PF-05082566 in Portion A.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B
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
Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B | 0 Participants |
Secondary
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
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
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 7 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 10 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 20 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 4 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 7 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 6 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 7 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 6 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 8 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 12 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 6 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 4 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 4 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 1 | 6 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 1 | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 2 | 5 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphopenia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 1 | 6 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Lymphocyte count increased, Grade 2 | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Anemia, Grade 3 | 0 Participants |
Secondary
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 4 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 16 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 11 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 11 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 6 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 9 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 3 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 5 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Anemia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphopenia, Grade 3 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 4 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Lymphocyte count increased, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | White blood cells, Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Neutrophils (absolute), Grade 2 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Hemoglobin increased, Grade 1 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B | Platelets, Grade 1 | 0 Participants |
Secondary
Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For PF-05082566 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B | For rituximab | 0 Participants |
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A
ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer\>=6.23.
Time frame: Up to approximately 2 years
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and was tested for ADA.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 4 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 5 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 20 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 3 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 14 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A | 2 Participants |
Secondary
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 10 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 6 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 8 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >30 to <=60 msec | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >480 to <=500 msec | 1 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc >450 to <=480 msec | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A | QTc change >60 msec | 0 Participants |
Secondary
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 14 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 8 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 2 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >30 to <=60 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >500 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >480 to <=500 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc >450 to <=480 msec | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B | QTc change >60 msec | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
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
Population: All participants who received at least 1 dose of PF-05082566 in Portion A.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 5 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 4 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 39 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 13 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 4 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 25 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 3 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 4 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 10 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 8 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 26 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 5 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 5 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs | 9 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | AEs related to PF-05082566 | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs | 3 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | SAEs related to PF-05082566 | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
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
Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 4 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 3 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 4 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 17 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 17 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 3 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 30 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 2 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 3 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 4 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to rituximab | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs | 4 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to rituximab | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | SAEs related to PF-05082566 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs and SAEs in Portion B | AEs related to PF-05082566 | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
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
Population: All participants who received at least 1 dose of PF-05082566 in Portion A.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 14 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 9 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 12 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 9 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 8 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 7 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 3 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 4 | 0 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 2 | 4 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 3 | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 1 | 2 Participants |
| Portion A: PF-05082566 10mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Grade 5 | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
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
Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.006mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.03mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.06mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 3 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.12mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 2 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 0 Participants |
| Portion A: PF-05082566 0.18mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 1 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 0.24mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 1 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 2 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 0 Participants |
| Portion A: PF-05082566 0.3mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 5 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 7 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 1 Participants |
| Portion A: PF-05082566 0.6mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 17 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 1 Participants |
| Portion A: PF-05082566 1.2mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 3 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 1 Participants |
| Portion A: PF-05082566 2.4mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 4 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 3 | 0 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 2 | 3 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 1 | 1 Participants |
| Portion A: PF-05082566 5mg/kg | Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B | Grade 5 | 0 Participants |
Secondary
Overall Survival in Portion A
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)
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Overall Survival in Portion A | 4.6 months |
| Portion A: PF-05082566 0.03mg/kg | Overall Survival in Portion A | 4.0 months |
| Portion A: PF-05082566 0.06mg/kg | Overall Survival in Portion A | 7.6 months |
| Portion A: PF-05082566 0.12mg/kg | Overall Survival in Portion A | 13.3 months |
| Portion A: PF-05082566 0.18mg/kg | Overall Survival in Portion A | 5.9 months |
| Portion A: PF-05082566 0.24mg/kg | Overall Survival in Portion A | 9.0 months |
| Portion A: PF-05082566 0.3mg/kg | Overall Survival in Portion A | 24.5 months |
| Portion A: PF-05082566 0.6mg/kg | Overall Survival in Portion A | NA months |
| Portion A: PF-05082566 1.2mg/kg | Overall Survival in Portion A | 7.6 months |
| Portion A: PF-05082566 2.4mg/kg | Overall Survival in Portion A | 11.2 months |
| Portion A: PF-05082566 5mg/kg | Overall Survival in Portion A | 29.5 months |
| Portion A: PF-05082566 10mg/kg | Overall Survival in Portion A | 6.1 months |
Secondary
Overall Survival in Portion B
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)
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.03mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.06mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.12mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.18mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.24mg/kg | Overall Survival in Portion B | 50.2 months |
| Portion A: PF-05082566 0.3mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 0.6mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 1.2mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 2.4mg/kg | Overall Survival in Portion B | NA months |
| Portion A: PF-05082566 5mg/kg | Overall Survival in Portion B | NA months |
Secondary
Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 33.3 percentage of participants |
| Portion A: PF-05082566 0.03mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 0 percentage of participants |
| Portion A: PF-05082566 0.06mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 25.0 percentage of participants |
| Portion A: PF-05082566 0.12mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 66.7 percentage of participants |
| Portion A: PF-05082566 0.18mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 0 percentage of participants |
| Portion A: PF-05082566 0.24mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 0 percentage of participants |
| Portion A: PF-05082566 0.3mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 0 percentage of participants |
| Portion A: PF-05082566 0.6mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 25.8 percentage of participants |
| Portion A: PF-05082566 1.2mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 33.3 percentage of participants |
| Portion A: PF-05082566 2.4mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 20.0 percentage of participants |
| Portion A: PF-05082566 5mg/kg | Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B | 0 percentage of participants |
Secondary
Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A
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)
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.03mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.06mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.12mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.18mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.24mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 4.8 percentage of participants |
| Portion A: PF-05082566 0.3mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 0.6mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 25.0 percentage of participants |
| Portion A: PF-05082566 1.2mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 2.4mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 5mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
| Portion A: PF-05082566 10mg/kg | Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A | 0 percentage of participants |
Secondary
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
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | 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 | Cycle 1 | 8.212 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 251 |
| Portion A: PF-05082566 0.006mg/kg | 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 | Cycle 2 | 14.21 microgram*hour per milliliter (μg*hr/mL) | — |
| Portion A: PF-05082566 0.03mg/kg | 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 | Cycle 1 | 101.0 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 9 |
| Portion A: PF-05082566 0.03mg/kg | 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 | Cycle 2 | 105.2 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 49 |
| Portion A: PF-05082566 0.06mg/kg | 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 | Cycle 1 | 148.1 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 0.06mg/kg | 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 | Cycle 2 | 93.59 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 152 |
| Portion A: PF-05082566 0.12mg/kg | 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 | Cycle 1 | 389.4 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 58 |
| Portion A: PF-05082566 0.12mg/kg | 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 | Cycle 2 | 614.9 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 7 |
| Portion A: PF-05082566 0.18mg/kg | 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 | Cycle 2 | 808.0 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 53 |
| Portion A: PF-05082566 0.18mg/kg | 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 | Cycle 1 | 703.3 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 32 |
| Portion A: PF-05082566 0.24mg/kg | 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 | Cycle 1 | 481.1 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 48 |
| Portion A: PF-05082566 0.24mg/kg | 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 | Cycle 2 | 818.7 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 38 |
| Portion A: PF-05082566 0.3mg/kg | 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 | Cycle 2 | 1662 microgram*hour per milliliter (μg*hr/mL) | — |
| Portion A: PF-05082566 0.3mg/kg | 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 | Cycle 1 | 996.1 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 0.6mg/kg | 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 | Cycle 1 | 2165 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 0.6mg/kg | 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 | Cycle 2 | 1918 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 40 |
| Portion A: PF-05082566 1.2mg/kg | 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 | Cycle 1 | 2383 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 61 |
| Portion A: PF-05082566 1.2mg/kg | 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 | Cycle 2 | 4035 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 25 |
| Portion A: PF-05082566 2.4mg/kg | 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 | Cycle 1 | 5731 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 101 |
| Portion A: PF-05082566 2.4mg/kg | 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 | Cycle 2 | 6741 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 6 |
| Portion A: PF-05082566 5mg/kg | 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 | Cycle 2 | 18140 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 5mg/kg | 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 | Cycle 1 | 15540 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 22 |
| Portion A: PF-05082566 10mg/kg | 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 | Cycle 2 | 19900 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 51 |
| Portion A: PF-05082566 10mg/kg | 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 | Cycle 1 | 25520 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 24 |
Secondary
PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 169.8 μg*hr/mL | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 120 μg*hr/mL | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 187.5 μg*hr/mL | Geometric Coefficient of Variation 31 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 251.4 μg*hr/mL | Geometric Coefficient of Variation 17 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 667.0 μg*hr/mL | Geometric Coefficient of Variation 13 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 931.0 μg*hr/mL | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 1072 μg*hr/mL | Geometric Coefficient of Variation 57 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 989.5 μg*hr/mL | — |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 687.9 μg*hr/mL | Geometric Coefficient of Variation 43 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 960.8 μg*hr/mL | Geometric Coefficient of Variation 47 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 2000 μg*hr/mL | — |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 770.0 μg*hr/mL | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 2916 μg*hr/mL | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 1782 μg*hr/mL | — |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 4649 μg*hr/mL | Geometric Coefficient of Variation 25 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 3111 μg*hr/mL | Geometric Coefficient of Variation 36 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 8480 μg*hr/mL | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 7628 μg*hr/mL | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 18430 μg*hr/mL | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 20950 μg*hr/mL | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 2 | 22400 μg*hr/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A | Cycle 1 | 28280 μg*hr/mL | Geometric Coefficient of Variation 28 |
Secondary
PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 13.70 μg*hr/mL | Geometric Coefficient of Variation 181 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 130.8 μg*hr/mL | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 104.8 μg*hr/mL | Geometric Coefficient of Variation 9 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 224.4 μg*hr/mL | Geometric Coefficient of Variation 19 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 154.2 μg*hr/mL | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 503.9 μg*hr/mL | Geometric Coefficient of Variation 14 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 618.6 μg*hr/mL | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 864.1 μg*hr/mL | Geometric Coefficient of Variation 47 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 690.9 μg*hr/mL | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 538.6 μg*hr/mL | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 824.3 μg*hr/mL | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 1681 μg*hr/mL | — |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 1012 μg*hr/mL | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 2107 μg*hr/mL | Geometric Coefficient of Variation 43 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 2195 μg*hr/mL | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 4068 μg*hr/mL | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 2761 μg*hr/mL | Geometric Coefficient of Variation 34 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 8204 μg*hr/mL | Geometric Coefficient of Variation 36 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 7460 μg*hr/mL | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 15760 μg*hr/mL | Geometric Coefficient of Variation 20 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 19040 μg*hr/mL | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 2 | 20490 μg*hr/mL | Geometric Coefficient of Variation 17 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A | Cycle 1 | 25250 μg*hr/mL | Geometric Coefficient of Variation 23 |
Secondary
PF-05082566 AUCinf in Portion B
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.
Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had AUCinf data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUCinf in Portion B | 137.8 μg*hr/mL | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUCinf in Portion B | 407.0 μg*hr/mL | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUCinf in Portion B | 615.5 μg*hr/mL | — |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUCinf in Portion B | 1076 μg*hr/mL | Geometric Coefficient of Variation 38 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUCinf in Portion B | 824.1 μg*hr/mL | Geometric Coefficient of Variation 78 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUCinf in Portion B | 1421 μg*hr/mL | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUCinf in Portion B | 2070 μg*hr/mL | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUCinf in Portion B | 3703 μg*hr/mL | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUCinf in Portion B | 9439 μg*hr/mL | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUCinf in Portion B | 16790 μg*hr/mL | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUCinf in Portion B | 48870 μg*hr/mL | — |
Secondary
PF-05082566 AUClast in Portion B
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 121.1 μg*hr/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 176.2 μg*hr/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 342.6 μg*hr/mL | Geometric Coefficient of Variation 13 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 471.5 μg*hr/mL | Geometric Coefficient of Variation 7 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 513.7 μg*hr/mL | Geometric Coefficient of Variation 20 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 696.5 μg*hr/mL | Geometric Coefficient of Variation 17 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 1146 μg*hr/mL | Geometric Coefficient of Variation 35 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 854.1 μg*hr/mL | Geometric Coefficient of Variation 31 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 701.7 μg*hr/mL | Geometric Coefficient of Variation 72 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 733.7 μg*hr/mL | Geometric Coefficient of Variation 85 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 1511 μg*hr/mL | Geometric Coefficient of Variation 10 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 1130 μg*hr/mL | Geometric Coefficient of Variation 14 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 3013 μg*hr/mL | Geometric Coefficient of Variation 70 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 2373 μg*hr/mL | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 6193 μg*hr/mL | Geometric Coefficient of Variation 22 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 2772 μg*hr/mL | Geometric Coefficient of Variation 63 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 7955 μg*hr/mL | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 10970 μg*hr/mL | Geometric Coefficient of Variation 44 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 17120 μg*hr/mL | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 19410 μg*hr/mL | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUClast in Portion B | Cycle 2 | 48540 μg*hr/mL | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUClast in Portion B | Cycle 1 | 38180 μg*hr/mL | Geometric Coefficient of Variation 18 |
Secondary
PF-05082566 AUCtau in Portion B
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 125.0 μg*hr/mL | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 178.2 μg*hr/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 453.9 μg*hr/mL | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 345.0 μg*hr/mL | Geometric Coefficient of Variation 16 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 514.5 μg*hr/mL | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 701.8 μg*hr/mL | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 1072 μg*hr/mL | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 871.6 μg*hr/mL | Geometric Coefficient of Variation 32 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 712.0 μg*hr/mL | Geometric Coefficient of Variation 71 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 854.5 μg*hr/mL | — |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 1128 μg*hr/mL | Geometric Coefficient of Variation 15 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 1521 μg*hr/mL | Geometric Coefficient of Variation 10 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 3116 μg*hr/mL | Geometric Coefficient of Variation 63 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 2361 μg*hr/mL | Geometric Coefficient of Variation 39 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 5967 μg*hr/mL | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 3206 μg*hr/mL | Geometric Coefficient of Variation 32 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 10220 μg*hr/mL | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 8001 μg*hr/mL | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 18150 μg*hr/mL | Geometric Coefficient of Variation 39 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 17290 μg*hr/mL | Geometric Coefficient of Variation 32 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUCtau in Portion B | Cycle 1 | 38860 μg*hr/mL | Geometric Coefficient of Variation 17 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 AUCtau in Portion B | Cycle 2 | 48030 μg*hr/mL | Geometric Coefficient of Variation 16 |
Secondary
PF-05082566 Clearance (CL) in Portion A
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.2510 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2296 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3203 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 31 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2676 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 19 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.1800 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 13 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.1939 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.1823 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2082 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 47 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3490 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 42 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2906 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.1786 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3890 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2847 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 43 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.2054 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3861 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 36 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2950 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3145 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.3220 milliliter/hour/kilogram (mL/hr/kg) | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.2711 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.2626 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 1 | 0.3536 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 28 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Clearance (CL) in Portion A | Cycle 2 | 0.4883 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 17 |
Secondary
PF-05082566 CL in Portion B
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2178 mL/hr/kg | — |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1683 mL/hr/kg | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.1470 mL/hr/kg | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1325 mL/hr/kg | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.1950 mL/hr/kg | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1710 mL/hr/kg | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.1667 mL/hr/kg | Geometric Coefficient of Variation 38 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1681 mL/hr/kg | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2911 mL/hr/kg | Geometric Coefficient of Variation 78 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.2807 mL/hr/kg | — |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1976 mL/hr/kg | Geometric Coefficient of Variation 11 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2107 mL/hr/kg | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.1928 mL/hr/kg | Geometric Coefficient of Variation 63 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2900 mL/hr/kg | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.3241 mL/hr/kg | Geometric Coefficient of Variation 37 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.2011 mL/hr/kg | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2546 mL/hr/kg | — |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.2351 mL/hr/kg | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2973 mL/hr/kg | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.2756 mL/hr/kg | Geometric Coefficient of Variation 39 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 CL in Portion B | Cycle 1 | 0.2048 mL/hr/kg | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 CL in Portion B | Cycle 2 | 0.2080 mL/hr/kg | Geometric Coefficient of Variation 16 |
Secondary
PF-05082566 Cmax in Portion B
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 0.6284 μg/mL | Geometric Coefficient of Variation 11 |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 0.6838 μg/mL | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 1.569 μg/mL | Geometric Coefficient of Variation 12 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 1.948 μg/mL | Geometric Coefficient of Variation 6 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 2.673 μg/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 3.102 μg/mL | Geometric Coefficient of Variation 18 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 4.167 μg/mL | Geometric Coefficient of Variation 12 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 3.934 μg/mL | Geometric Coefficient of Variation 28 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 4.512 μg/mL | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 4.607 μg/mL | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 6.481 μg/mL | Geometric Coefficient of Variation 10 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 7.435 μg/mL | Geometric Coefficient of Variation 9 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 13.97 μg/mL | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 12.16 μg/mL | Geometric Coefficient of Variation 9 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 19.20 μg/mL | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 20.03 μg/mL | Geometric Coefficient of Variation 32 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 42.61 μg/mL | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 44.35 μg/mL | Geometric Coefficient of Variation 19 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 89.06 μg/mL | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 95.16 μg/mL | Geometric Coefficient of Variation 19 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Cmax in Portion B | Cycle 1 | 196.2 μg/mL | Geometric Coefficient of Variation 22 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Cmax in Portion B | Cycle 2 | 206.0 μg/mL | Geometric Coefficient of Variation 29 |
Secondary
PF-05082566 Ctrough in Portion B
Ctrough of PF-05082566 was observed directly from data.
Time frame: Day 1 pre-dose of Cycle 2
Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had data for Ctrough.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Ctrough in Portion B | 0.1267 μg/mL | Geometric Coefficient of Variation 47 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Ctrough in Portion B | 0.2853 μg/mL | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Ctrough in Portion B | 0.3922 μg/mL | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Ctrough in Portion B | 0.4698 μg/mL | Geometric Coefficient of Variation 53 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Ctrough in Portion B | 0.3539 μg/mL | Geometric Coefficient of Variation 110 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Ctrough in Portion B | 0.6001 μg/mL | Geometric Coefficient of Variation 48 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Ctrough in Portion B | 1.486 μg/mL | Geometric Coefficient of Variation 90 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Ctrough in Portion B | 1.452 μg/mL | Geometric Coefficient of Variation 62 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Ctrough in Portion B | 5.560 μg/mL | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Ctrough in Portion B | 12.16 μg/mL | Geometric Coefficient of Variation 63 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Ctrough in Portion B | 31.34 μg/mL | Geometric Coefficient of Variation 36 |
Secondary
PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 0.1515 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 12 |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 0.1250 micrograms per milliliter (μg/mL) | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 0.5049 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 7 |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 0.4952 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 34 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 1.093 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 47 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 1.014 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 2.614 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 3.408 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 25 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 4.219 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 16 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 4.013 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 25 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 2.955 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 46 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 3.246 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 30 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 7.038 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 23 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 8.349 micrograms per milliliter (μg/mL) | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 14.80 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 11.72 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 28 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 17.61 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 36 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 18.02 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 58.38 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 33 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 49.63 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 97.75 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 13 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 101.6 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 17 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 2 | 167.0 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Cycle 1 | 150.3 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 24 |
Secondary
PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A
Ctrough of PF-05082566 was observed directly from data.
Time frame: Day 1 pre-dose of Cycle 2
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | NA μg/mL | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.1063 μg/mL | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.1092 μg/mL | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.3268 μg/mL | Geometric Coefficient of Variation 12 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.4285 μg/mL | Geometric Coefficient of Variation 49 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.3868 μg/mL | Geometric Coefficient of Variation 46 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 0.8597 μg/mL | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 1.520 μg/mL | Geometric Coefficient of Variation 22 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 1.313 μg/mL | Geometric Coefficient of Variation 61 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 7.054 μg/mL | Geometric Coefficient of Variation 52 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 9.934 μg/mL | Geometric Coefficient of Variation 35 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | 9.963 μg/mL | Geometric Coefficient of Variation 250 |
Secondary
PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A
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.
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.75 hours (hr) |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 13.0 hours (hr) |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.63 hours (hr) |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.50 hours (hr) |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 2.00 hours (hr) |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.54 hours (hr) |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.26 hours (hr) |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.00 hours (hr) |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 2.00 hours (hr) |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.25 hours (hr) |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.03 hours (hr) |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.03 hours (hr) |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.00 hours (hr) |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.00 hours (hr) |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.80 hours (hr) |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.46 hours (hr) |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.17 hours (hr) |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.02 hours (hr) |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.50 hours (hr) |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.08 hours (hr) |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.92 hours (hr) |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.06 hours (hr) |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 2 | 1.31 hours (hr) |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Cycle 1 | 1.50 hours (hr) |
Secondary
PF-05082566 Tmax in Portion B
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.
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.50 hr |
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.05 hr |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.08 hr |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.52 hr |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.04 hr |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.06 hr |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 2.00 hr |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.57 hr |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.52 hr |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.00 hr |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.17 hr |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.50 hr |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 2.00 hr |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.33 hr |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.02 hr |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 1.06 hr |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 2.00 hr |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.50 hr |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 2.00 hr |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.50 hr |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Tmax in Portion B | Cycle 1 | 2.00 hr |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Tmax in Portion B | Cycle 2 | 1.28 hr |
Secondary
PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 65.50 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 102.1 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 101.1 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 20 |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 74.11 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 83.63 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 15 |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 90.80 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 74.38 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 81.69 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 27 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 110.7 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 28 |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 86.50 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 51.00 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 75.20 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 61.54 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 82.38 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 112.2 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 29 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 116.5 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 62 |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 110.4 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 99.80 milliliter per kilogram (mL/kg) | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 97.07 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 26 |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 87.37 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 43 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 1 | 125.5 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 21 |
| Portion A: PF-05082566 10mg/kg | PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A | Cycle 2 | 139.5 milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 29 |
Secondary
PF-05082566 Vss in Portion B
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.
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 81.87 mL/kg | — |
| Portion A: PF-05082566 0.03mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 78.60 mL/kg | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 79.93 mL/kg | — |
| Portion A: PF-05082566 0.06mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 81.90 mL/kg | — |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 65.42 mL/kg | — |
| Portion A: PF-05082566 0.12mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 66.90 mL/kg | Geometric Coefficient of Variation 24 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 93.68 mL/kg | Geometric Coefficient of Variation 54 |
| Portion A: PF-05082566 0.18mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 85.51 mL/kg | — |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 66.27 mL/kg | — |
| Portion A: PF-05082566 0.24mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 85.12 mL/kg | Geometric Coefficient of Variation 4 |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 126.0 mL/kg | — |
| Portion A: PF-05082566 0.3mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 100.5 mL/kg | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 86.99 mL/kg | — |
| Portion A: PF-05082566 0.6mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 102.8 mL/kg | Geometric Coefficient of Variation 20 |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 130.9 mL/kg | — |
| Portion A: PF-05082566 1.2mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 94.00 mL/kg | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 98.98 mL/kg | — |
| Portion A: PF-05082566 2.4mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 102.2 mL/kg | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Vss in Portion B | Cycle 2 | 95.89 mL/kg | — |
| Portion A: PF-05082566 5mg/kg | PF-05082566 Vss in Portion B | Cycle 1 | 94.08 mL/kg | — |
Secondary
Progression-Free Survival in Portion A
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)
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Progression-Free Survival in Portion A | 1.7 months |
| Portion A: PF-05082566 0.03mg/kg | Progression-Free Survival in Portion A | 3.6 months |
| Portion A: PF-05082566 0.06mg/kg | Progression-Free Survival in Portion A | 1.7 months |
| Portion A: PF-05082566 0.12mg/kg | Progression-Free Survival in Portion A | 3.5 months |
| Portion A: PF-05082566 0.18mg/kg | Progression-Free Survival in Portion A | 1.7 months |
| Portion A: PF-05082566 0.24mg/kg | Progression-Free Survival in Portion A | 2.1 months |
| Portion A: PF-05082566 0.3mg/kg | Progression-Free Survival in Portion A | 1.6 months |
| Portion A: PF-05082566 0.6mg/kg | Progression-Free Survival in Portion A | 3.5 months |
| Portion A: PF-05082566 1.2mg/kg | Progression-Free Survival in Portion A | 1.7 months |
| Portion A: PF-05082566 2.4mg/kg | Progression-Free Survival in Portion A | 1.1 months |
| Portion A: PF-05082566 5mg/kg | Progression-Free Survival in Portion A | 3.3 months |
| Portion A: PF-05082566 10mg/kg | Progression-Free Survival in Portion A | 1.8 months |
Secondary
Progression-Free Survival in Portion B
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)
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Progression-Free Survival in Portion B | NA months |
| Portion A: PF-05082566 0.03mg/kg | Progression-Free Survival in Portion B | 8.1 months |
| Portion A: PF-05082566 0.06mg/kg | Progression-Free Survival in Portion B | 11.8 months |
| Portion A: PF-05082566 0.12mg/kg | Progression-Free Survival in Portion B | 9.9 months |
| Portion A: PF-05082566 0.18mg/kg | Progression-Free Survival in Portion B | 2.1 months |
| Portion A: PF-05082566 0.24mg/kg | Progression-Free Survival in Portion B | 5.7 months |
| Portion A: PF-05082566 0.3mg/kg | Progression-Free Survival in Portion B | 4.8 months |
| Portion A: PF-05082566 0.6mg/kg | Progression-Free Survival in Portion B | 3.9 months |
| Portion A: PF-05082566 1.2mg/kg | Progression-Free Survival in Portion B | 16.3 months |
| Portion A: PF-05082566 2.4mg/kg | Progression-Free Survival in Portion B | 3.9 months |
| Portion A: PF-05082566 5mg/kg | Progression-Free Survival in Portion B | 3.0 months |
Secondary
Rituximab Cmax and Ctrough in Portion B
Cmax and Ctrough of rituximab were observed directly from data.
Time frame: Day 1 pre-dose of Cycle 2
Population: 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.
Secondary
Time to Response in Portion A
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)
Population: All participants who received at least 1 dose of PF-05082566 in Portion A and and achieved an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.24mg/kg | Time to Response in Portion A | 10.3 months |
| Portion A: PF-05082566 0.6mg/kg | Time to Response in Portion A | 1.8 months |
Secondary
Time to Response in Portion B
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)
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Portion A: PF-05082566 0.006mg/kg | Time to Response in Portion B | 2.1 months |
| Portion A: PF-05082566 0.06mg/kg | Time to Response in Portion B | 2.1 months |
| Portion A: PF-05082566 0.12mg/kg | Time to Response in Portion B | 2.0 months |
| Portion A: PF-05082566 0.6mg/kg | Time to Response in Portion B | 2.1 months |
| Portion A: PF-05082566 1.2mg/kg | Time to Response in Portion B | 3.9 months |
| Portion A: PF-05082566 2.4mg/kg | Time to Response in Portion B | 7.4 months |
Other Pre-specified
Biomarkers Linked With Immunomodulation and Cytokine Release
This was an exploratory endpoint and no data were collected.
Time frame: Days 1, 14, 29 and 57
Population: This was an exploratory endpoint and no data were collected.
Other Pre-specified
Exploratory Pharmacodynamic Biomarkers
This was an exploratory endpoint and no data were collected.
Time frame: Days 1 and 21
Population: This was an exploratory endpoint and no data were collected.
Other Pre-specified
Patient-Reported Outcomes of PF-05082566 and Rituximab When Given in Combination in Follicular Lymphoma Participants
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
Population: This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.