Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors
Brief summary
This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors.
Interventions
DRUGPF-05082566
Starting dose of 0.45 mg/kg q3wks IV, dose escalation
DRUGMK-3475
2 mg/kg q3wks, IV
Sponsors
Merck Sharp & Dohme LLC
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available. * Measurable disease per RECIST v1.1. * Adequate bone marrow, renal and liver functioning
Exclusion criteria
* CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis. * History of any of the following toxicities associated with a prior immunotherapy: * Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy; * Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy * Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. * History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | First 2 cycles of treatment up to 24 months | Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\>=3 neutropenic infection; Grade\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\>=3 toxicities (non-laboratory); Grade\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Baseline up to 90 days after the last dose of study drug, approximately 27 months | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. |
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Baseline up to 90 days after the last dose of study drug, approximately 27 months | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. |
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Baseline up to 90 days after the last dose of study drug, approximately 27 months | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. |
| Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Baseline up to 28 days after the last dose of study drug, approximately 25 months | The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed. |
| Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Baseline up to 28 days after the last dose of study drug, approximately 25 months | The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed. |
| Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | Baseline up to 28 days after the last dose of study drug, approximately 25 months | Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator. |
| Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | Baseline up to 28 days after the last dose of study drug, approximately 25 months | The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair. |
| Maximum Observed Serum Concentration (Cmax) of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion | Maximum PF-05082566 observed serum concentration. |
| Maximum Observed Serum Concentration (Cmax) of MK-3475 | During Cycle 5 Day 1 at pre-dose; and end of infusion. | Maximum MK-3475 observed serum concentration. |
| Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Baseline up to 90 days after the last dose of study drug, approximately 27 months | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. |
| Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | PF-05082566 pre-dose concentration during multiple dosing |
| Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | During Cycle 5 Day 1 at pre-dose; and end of infusion. | MK-3475 pre-dose concentration during multiple dosing |
| Terminal Half-life （t½）of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | PF-05082566 terminal half-life |
| Clearance (CL) of Study Drug of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | Clearance of PF-05082566 |
| Volume of Distribution at Steady State (Vss) of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | PF-05082566 volume of distribution at steady state |
| Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau) |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter | ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer\<6.23; Positive ADA: titer\>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration. |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment). | ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs. |
| Number of Participants With Objective Tumor Response | Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated. | Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression\<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)\>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. |
| Time for Cmax (Tmax) of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. | Time to reach PF-05082566 maximum observed serum concentration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. | 5 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 3 |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 3 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. | 3 |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 9 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Other | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Progressive Disease | 4 | 1 | 1 | 2 | 6 |
| Overall Study | Subject refused further follow-up | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 15.4 | 62.0 years STANDARD_DEVIATION 11.4 | 51.7 years STANDARD_DEVIATION 22 | 54.7 years STANDARD_DEVIATION 21 | 58.8 years STANDARD_DEVIATION 19.4 | 58.0 years STANDARD_DEVIATION 16.9 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 3 Participants | 0 Participants | 3 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 5 Participants | 14 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 5 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 9 |
| other Total, other adverse events | 5 / 5 | 3 / 3 | 3 / 3 | 3 / 3 | 9 / 9 |
| serious Total, serious adverse events | 2 / 5 | 0 / 3 | 1 / 3 | 2 / 3 | 5 / 9 |
Outcome results
Primary
Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475
Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\>=3 neutropenic infection; Grade\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\>=3 toxicities (non-laboratory); Grade\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.
Time frame: First 2 cycles of treatment up to 24 months
Population: The DLT evaluable set was a subset of the safety analysis set and included all participants who were eligible, received both study treatments and who either experienced a DLT during the first 2 cycles of PF-05082566 or completed the 2 cycles' DLT observation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
| Total | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | 0 Participants |
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566
PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau)
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | 1093 µg•hr/mL | Geometric Coefficient of Variation 32 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | 1800 µg•hr/mL | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | 3477 µg•hr/mL | Geometric Coefficient of Variation 41 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | 9253 µg•hr/mL | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | 10480 µg•hr/mL | Geometric Coefficient of Variation 25 |
Secondary
Clearance (CL) of Study Drug of PF-05082566
Clearance of PF-05082566
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Clearance (CL) of Study Drug of PF-05082566 | 0.4120 mL/hr/kg | Geometric Coefficient of Variation 32 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Clearance (CL) of Study Drug of PF-05082566 | 0.5000 mL/hr/kg | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Clearance (CL) of Study Drug of PF-05082566 | 0.5182 mL/hr/kg | Geometric Coefficient of Variation 41 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Clearance (CL) of Study Drug of PF-05082566 | 0.3894 mL/hr/kg | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Clearance (CL) of Study Drug of PF-05082566 | 0.4763 mL/hr/kg | Geometric Coefficient of Variation 25 |
Secondary
Maximum Observed Serum Concentration (Cmax) of MK-3475
Maximum MK-3475 observed serum concentration.
Time frame: During Cycle 5 Day 1 at pre-dose; and end of infusion.
Population: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of MK-3475 | 63350 ng/mL | Geometric Coefficient of Variation 22 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of MK-3475 | 71300 ng/mL | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of MK-3475 | 61090 ng/mL | Geometric Coefficient of Variation 7 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of MK-3475 | 51920 ng/mL | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of MK-3475 | 62030 ng/mL | Geometric Coefficient of Variation 32 |
Secondary
Maximum Observed Serum Concentration (Cmax) of PF-05082566
Maximum PF-05082566 observed serum concentration.
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion
Population: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | 7.628 µg/mL | Geometric Coefficient of Variation 25 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | 18.70 µg/mL | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | 29.80 µg/mL | Geometric Coefficient of Variation 16 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | 60.35 µg/mL | Geometric Coefficient of Variation 39 |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | 95.57 µg/mL | Geometric Coefficient of Variation 16 |
Secondary
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern
Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator.
Time frame: Baseline up to 28 days after the last dose of study drug, approximately 25 months
Population: The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
| Total | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | 0 Participants |
Secondary
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries)
The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed.
Time frame: Baseline up to 28 days after the last dose of study drug, approximately 25 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 3 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 3 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 3 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 6 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 7 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 2 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 2 | 5 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 0-1 | 18 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 3-4 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 2 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Bilirubin (Total) Grade 0-1 | 21 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypernatremia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | AST Grade 2 | 2 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Aspartate Aminotransferase (AST) Grade 0-1 | 21 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 0-1 | 16 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 3-4 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 2 | 4 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 2 | 2 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alkaline Phosphatase Grade 0-1 | 20 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoalbuminemia Grade 3-4 | 3 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | ALT Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 3-4 | 2 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Creatinine Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Alanine Aminotransferase (ALT) Grade 0-1 | 22 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 3-4 | 2 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypocalcemia Grade 3 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypomagnesemia Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 0-1 | 22 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 2 | 6 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypophosphatemia Grade 0-1 | 15 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 2 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 3-4 | 4 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypoglycemia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyponatremia Grade 0-1 | 19 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 2 | 4 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 0-1 | 17 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 2 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperglycemia Grade 3-4 | 2 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 0 | 22 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypercalcemia Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hyperkalemia Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypokalemia Grade 0-1 | 21 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | Hypermagnesemia Grade 0-1 | 23 Participants |
Secondary
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology)
The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed.
Time frame: Baseline up to 28 days after the last dose of study drug, approximately 25 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 3 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 5 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 8 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 6 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 7 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 2 | 4 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 2 | 6 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 0-1 | 14 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 0-1 | 19 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 3-4 | 7 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 0-1 | 22 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 2 | 9 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | White Blood Cells Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Neutrophils (Absolute) Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 0-1 | 23 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphocyte Count Increased Grade 3-4 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Platelets Grade 2 | 1 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Lymphopenia Grade 0-1 | 7 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Hemoglobin Increased Grade 2 | 0 Participants |
| Total | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | Anemia Grade 3-4 | 3 Participants |
Secondary
Number of Participants With Objective Tumor Response
Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression\<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)\>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Time frame: Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated.
Population: The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 treatment the participant was classified according to the first treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Stable disease | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Complete response | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective progression | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Partial response | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective progression | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Stable disease | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Complete response | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Partial response | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective progression | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Partial response | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Complete response | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Stable disease | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Stable disease | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Partial response | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Complete response | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective progression | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Stable disease | 3 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Complete response | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Partial response | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective progression | 4 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 2 Participants |
| Total | Number of Participants With Objective Tumor Response | Stable disease | 10 Participants |
| Total | Number of Participants With Objective Tumor Response | Partial response | 4 Participants |
| Total | Number of Participants With Objective Tumor Response | Complete response | 2 Participants |
| Total | Number of Participants With Objective Tumor Response | Objective response rate (CR+PR) | 6 Participants |
| Total | Number of Participants With Objective Tumor Response | Objective progression | 7 Participants |
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475
ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.
Time frame: Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment).
Population: The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | 0 Participants |
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566
ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer\<6.23; Positive ADA: titer\>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration.
Time frame: Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter
Population: The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 4 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 4 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 5 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 4 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-induced ADA | 15 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Overall ADA Incidence | 15 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Treatment-boosted ADA | 0 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA Anytime | 17 Participants |
| Total | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | Pre-dose ADA | 2 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related)
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time frame: Baseline up to 90 days after the last dose of study drug, approximately 27 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 6 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 4 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 1 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 5 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 3 | 2 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 1 | 8 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | AE | 18 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 4 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | SAE | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | Grade 2 | 8 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time frame: Baseline up to 90 days after the last dose of study drug, approximately 27 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 6 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 4 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 1 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 5 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 3 | 2 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade1 | 8 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | AE | 1 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 4 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | SAE | 18 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | Grade 2 | 8 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time frame: Baseline up to 90 days after the last dose of study drug, approximately 27 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 4 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 1 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 6 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 4 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 1 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 5 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 3 | 2 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 1 | 8 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | AE | 18 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 4 | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | SAE | 0 Participants |
| Total | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | Grade 2 | 8 Participants |
Secondary
Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study
The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair.
Time frame: Baseline up to 28 days after the last dose of study drug, approximately 25 months
Population: The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 4 Participants |
| Total | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 1 | 7 Participants |
| Total | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 3 | 4 Participants |
| Total | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 4 and 5 | 0 Participants |
| Total | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | ECOG Performance Status worst to 2 | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.
Time frame: Baseline up to 90 days after the last dose of study drug, approximately 27 months
Population: The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 2 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 5 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 1 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 0 Participants |
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 2 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 3 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 1 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 2 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 3 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 1 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 0 Participants |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 0 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 2 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 3 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 1 Participants |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 9 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 5 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 0 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 2 Participants |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 7 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 5 | 1 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 3 | 12 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 1 | 4 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | AE | 23 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 4 | 1 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | SAE | 10 Participants |
| Total | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | Grade 2 | 5 Participants |
Secondary
Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475
MK-3475 pre-dose concentration during multiple dosing
Time frame: During Cycle 5 Day 1 at pre-dose; and end of infusion.
Population: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | 18460 ng/mL | Geometric Coefficient of Variation 33 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | 19200 ng/mL | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | 20390 ng/mL | Geometric Coefficient of Variation 15 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | 11250 ng/mL | Geometric Coefficient of Variation 78 |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | 17280 ng/mL | Geometric Coefficient of Variation 46 |
Secondary
Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566
PF-05082566 pre-dose concentration during multiple dosing
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | 0.7489 µg/mL | Geometric Coefficient of Variation 33 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | 1.210 µg/mL | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | 1.664 µg/mL | Geometric Coefficient of Variation 35 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | 5.167 µg/mL | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | 7.796 µg/mL | Geometric Coefficient of Variation 9 |
Secondary
Terminal Half-life （t½）of PF-05082566
PF-05082566 terminal half-life
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Terminal Half-life （t½）of PF-05082566 | 179.3 hour | Standard Deviation 24.338 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Terminal Half-life （t½）of PF-05082566 | 173.0 hour | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Terminal Half-life （t½）of PF-05082566 | 144.7 hour | Standard Deviation 31.628 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Terminal Half-life （t½）of PF-05082566 | 174.5 hour | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Terminal Half-life （t½）of PF-05082566 | 164.8 hour | Standard Deviation 49.564 |
Secondary
Time for Cmax (Tmax) of PF-05082566
Time to reach PF-05082566 maximum observed serum concentration.
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Time for Cmax (Tmax) of PF-05082566 | 1.44 hour |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Time for Cmax (Tmax) of PF-05082566 | 5.40 hour |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Time for Cmax (Tmax) of PF-05082566 | 1.07 hour |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Time for Cmax (Tmax) of PF-05082566 | 1.08 hour |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Time for Cmax (Tmax) of PF-05082566 | 1.15 hour |
Secondary
Volume of Distribution at Steady State (Vss) of PF-05082566
PF-05082566 volume of distribution at steady state
Time frame: During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.
Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | Volume of Distribution at Steady State (Vss) of PF-05082566 | 101.4 mL/kg | Geometric Coefficient of Variation 45 |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | Volume of Distribution at Steady State (Vss) of PF-05082566 | 112.0 mL/kg | — |
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | Volume of Distribution at Steady State (Vss) of PF-05082566 | 104.0 mL/kg | Geometric Coefficient of Variation 18 |
| PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | Volume of Distribution at Steady State (Vss) of PF-05082566 | 93.19 mL/kg | — |
| PF-05082566 5 mg/kg + MK-3475 2 mg/kg | Volume of Distribution at Steady State (Vss) of PF-05082566 | 104.6 mL/kg | Geometric Coefficient of Variation 13 |