Trial Outcomes & Findings for A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036) (NCT NCT02179918)

Last Updated: 2019-02-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

First 2 cycles of treatment up to 24 months

Results posted on

2019-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	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 every 3 weeks (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.	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.	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.	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.	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.
Overall Study COMPLETED	1	0	1	0	1
Overall Study NOT COMPLETED	4	3	2	3	8
Overall Study STARTED	5	3	3	3	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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 every 3 weeks (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.	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.	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.	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.	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.
Overall Study Death	0	0	0	1	0
Overall Study Lost to Follow-up	0	0	1	0	0
Overall Study Progressive Disease	4	1	1	2	6
Overall Study Other	0	1	0	0	1
Overall Study Subject refused further follow-up	0	1	0	0	1

Baseline Characteristics

A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Total of all reporting groups
Age, Continuous	60.0 years STANDARD_DEVIATION 15.4 • n=5 Participants	62.0 years STANDARD_DEVIATION 11.4 • n=7 Participants	51.7 years STANDARD_DEVIATION 22 • n=5 Participants	54.7 years STANDARD_DEVIATION 21 • n=4 Participants	58.8 years STANDARD_DEVIATION 19.4 • n=21 Participants	58.0 years STANDARD_DEVIATION 16.9 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	14 Participants n=8 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	15 Participants n=8 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) SAE	2 Participants	0 Participants	1 Participants	2 Participants	5 Participants	10 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) AE	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) Grade 1	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) Grade 2	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	5 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) Grade 3	2 Participants	1 Participants	1 Participants	1 Participants	7 Participants	12 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) Grade 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) Grade 5	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) AE	4 Participants	3 Participants	3 Participants	2 Participants	6 Participants	18 Participants
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	3 Participants	2 Participants	1 Participants	1 Participants	8 Participants
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	0 Participants	1 Participants	0 Participants	4 Participants	8 Participants
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	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) SAE	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	18 Participants
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	0 Participants	1 Participants	0 Participants	4 Participants	8 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) AE	4 Participants	3 Participants	3 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) Grade1	1 Participants	3 Participants	2 Participants	1 Participants	1 Participants	8 Participants
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	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) AE	4 Participants	3 Participants	3 Participants	2 Participants	6 Participants	18 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) Grade 1	1 Participants	3 Participants	2 Participants	1 Participants	1 Participants	8 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) Grade 2	3 Participants	0 Participants	1 Participants	0 Participants	4 Participants	8 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) Grade 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Anemia Grade 0-1	3 Participants	2 Participants	2 Participants	1 Participants	6 Participants	14 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Anemia Grade 2	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants	6 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Anemia Grade 3-4	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Hemoglobin Increased Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Hemoglobin Increased Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Hemoglobin Increased Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphocyte Count Increased Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphocyte Count Increased Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphopenia Grade 0-1	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	7 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphopenia Grade 2	2 Participants	0 Participants	2 Participants	0 Participants	5 Participants	9 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphopenia Grade 3-4	2 Participants	1 Participants	0 Participants	2 Participants	2 Participants	7 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Neutrophils (Absolute) Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Neutrophils (Absolute) Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Neutrophils (Absolute) Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Platelets Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	8 Participants	22 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Platelets Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Platelets Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) White Blood Cells Grade 0-1	4 Participants	3 Participants	2 Participants	3 Participants	7 Participants	19 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) White Blood Cells Grade 2	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) White Blood Cells Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) Lymphocyte Count Increased Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Alkaline Phosphatase Grade 3-4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Aspartate Aminotransferase (AST) Grade 0-1	4 Participants	3 Participants	3 Participants	3 Participants	8 Participants	21 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperglycemia Grade 0-1	3 Participants	2 Participants	3 Participants	1 Participants	8 Participants	17 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypophosphatemia Grade 0-1	4 Participants	3 Participants	2 Participants	0 Participants	6 Participants	15 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypophosphatemia Grade 2	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants	6 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypokalemia Grade 0-1	5 Participants	3 Participants	3 Participants	2 Participants	8 Participants	21 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypokalemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypercalcemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypercalcemia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperglycemia Grade 2	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperglycemia Grade 3-4	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperkalemia Grade 0	4 Participants	3 Participants	3 Participants	3 Participants	9 Participants	22 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperkalemia Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyperkalemia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypermagnesemia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypermagnesemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypermagnesemia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypernatremia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypernatremia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypernatremia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoalbuminemia Grade 0-1	3 Participants	3 Participants	1 Participants	1 Participants	8 Participants	16 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoalbuminemia Grade 2	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoalbuminemia Grade 3-4	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypocalcemia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypocalcemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypocalcemia Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoglycemia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	8 Participants	22 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoglycemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypoglycemia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Alanine Aminotransferase (ALT) Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	8 Participants	22 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) ALT Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) ALT Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Alkaline Phosphatase Grade 0-1	4 Participants	3 Participants	3 Participants	1 Participants	9 Participants	20 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Alkaline Phosphatase Grade 2	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypokalemia Grade 3-4	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypomagnesemia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypomagnesemia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) AST Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) AST Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypomagnesemia Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyponatremia Grade 0-1	4 Participants	3 Participants	2 Participants	2 Participants	8 Participants	19 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Bilirubin (Total) Grade 0-1	5 Participants	2 Participants	3 Participants	3 Participants	8 Participants	21 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Bilirubin (Total) Grade 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyponatremia Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hyponatremia Grade 3-4	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Bilirubin (Total) Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Creatinine Grade 0-1	4 Participants	2 Participants	3 Participants	2 Participants	7 Participants	18 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Creatinine Grade 2	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	5 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Creatinine Grade 3-4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypercalcemia Grade 0-1	5 Participants	3 Participants	3 Participants	3 Participants	9 Participants	23 Participants
Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) Hypophosphatemia Grade 3-4	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
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	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
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	0 Participants	0 Participants	1 Participants	2 Participants	4 Participants
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	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
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	2 Participants	0 Participants	1 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Maximum PF-05082566 observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Maximum Observed Serum Concentration (Cmax) of PF-05082566	7.628 µg/mL Geometric Coefficient of Variation 25	18.70 µg/mL Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	29.80 µg/mL Geometric Coefficient of Variation 16	60.35 µg/mL Geometric Coefficient of Variation 39	95.57 µg/mL Geometric Coefficient of Variation 16	—

SECONDARY outcome

Timeframe: During Cycle 5 Day 1 at pre-dose; and end of infusion.

Maximum MK-3475 observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Maximum Observed Serum Concentration (Cmax) of MK-3475	63350 ng/mL Geometric Coefficient of Variation 22	71300 ng/mL Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	61090 ng/mL Geometric Coefficient of Variation 7	51920 ng/mL Geometric Coefficient of Variation NA Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 46000 and 58600 ng/mL, respectively	62030 ng/mL Geometric Coefficient of Variation 32	—

SECONDARY outcome

Timeframe: 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.

Time to reach PF-05082566 maximum observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Time for Cmax (Tmax) of PF-05082566	1.44 hour Interval 1.0 to 1.98	5.40 hour Interval 5.4 to 5.4	1.07 hour Interval 1.03 to 2.03	1.08 hour Interval 1.07 to 1.25	1.15 hour Interval 1.0 to 6.0	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566	0.7489 µg/mL Geometric Coefficient of Variation 33	1.210 µg/mL Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	1.664 µg/mL Geometric Coefficient of Variation 35	5.167 µg/mL Geometric Coefficient of Variation NA Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 4.32 and 6.18 µg/mL, respectively.	7.796 µg/mL Geometric Coefficient of Variation 9	—

SECONDARY outcome

Timeframe: During Cycle 5 Day 1 at pre-dose; and end of infusion.

MK-3475 pre-dose concentration during multiple dosing

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475	18460 ng/mL Geometric Coefficient of Variation 33	19200 ng/mL Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	20390 ng/mL Geometric Coefficient of Variation 15	11250 ng/mL Geometric Coefficient of Variation 78	17280 ng/mL Geometric Coefficient of Variation 46	—

SECONDARY outcome

Timeframe: 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.

PF-05082566 terminal half-life

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Terminal Half-life （t½）of PF-05082566	179.3 hour Standard Deviation 24.338	173.0 hour Standard Deviation NA Only 1 participant was analyzed, therefore the standard deviation was not applicable.	144.7 hour Standard Deviation 31.628	174.5 hour Standard Deviation NA Only 2 participant were analyzed, therefore the standard deviation was not applicable. Individual subject values are 141and 208 hour, respectively.	164.8 hour Standard Deviation 49.564	—

SECONDARY outcome

Timeframe: 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.

Clearance of PF-05082566

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Clearance (CL) of Study Drug of PF-05082566	0.4120 mL/hr/kg Geometric Coefficient of Variation 32	0.5000 mL/hr/kg Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	0.5182 mL/hr/kg Geometric Coefficient of Variation 41	0.3894 mL/hr/kg Geometric Coefficient of Variation NA Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 0.254 and 0.597 mL/hr/kg, respectively.	0.4763 mL/hr/kg Geometric Coefficient of Variation 25	—

SECONDARY outcome

Timeframe: 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.

PF-05082566 volume of distribution at steady state

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Volume of Distribution at Steady State (Vss) of PF-05082566	101.4 mL/kg Geometric Coefficient of Variation 45	112.0 mL/kg Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	104.0 mL/kg Geometric Coefficient of Variation 18	93.19 mL/kg Geometric Coefficient of Variation NA Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 52.0 and 167 mL/kg, respectively.	104.6 mL/kg Geometric Coefficient of Variation 13	—

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=1 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=2 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=4 Participants 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.	Total Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
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	1800 µg•hr/mL Geometric Coefficient of Variation NA Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.	3477 µg•hr/mL Geometric Coefficient of Variation 41	9253 µg•hr/mL Geometric Coefficient of Variation NA Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 6030 and 14200 µg•hr/mL, respectively.	10480 µg•hr/mL Geometric Coefficient of Variation 25	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 Pre-dose ADA	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 ADA Anytime	4 Participants	3 Participants	2 Participants	3 Participants	5 Participants	17 Participants
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 Treatment-induced ADA	4 Participants	3 Participants	2 Participants	2 Participants	4 Participants	15 Participants
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 Treatment-boosted ADA	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 Overall ADA Incidence	4 Participants	3 Participants	2 Participants	2 Participants	4 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 Participants 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 Participants 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 Participants 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.	Total n=23 Participants Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.
Number of Participants With Objective Tumor Response Complete response	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Objective Tumor Response Partial response	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Objective Tumor Response Stable disease	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	10 Participants
Number of Participants With Objective Tumor Response Objective progression	1 Participants	1 Participants	1 Participants	0 Participants	4 Participants	7 Participants
Number of Participants With Objective Tumor Response Objective response rate (CR+PR)	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	6 Participants

Adverse Events

PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-05082566 5 mg/kg + MK-3475 2 mg/kg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 participants at risk 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Disease progression	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Inflammation	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Herpes simplex	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Pneumonia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Sinusitis	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Spinal cord compression	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months

Other adverse events

Other adverse events
Measure	PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg n=5 participants at risk 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.	PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg n=3 participants at risk 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.	PF-05082566 5 mg/kg + MK-3475 2 mg/kg n=9 participants at risk 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.
Psychiatric disorders Anxiety	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Cardiac disorders Sinus tachycardia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Ear and labyrinth disorders Ear discomfort	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Ear and labyrinth disorders Ear pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Ear and labyrinth disorders Vertigo	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Endocrine disorders Adrenal insufficiency	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Endocrine disorders Hyperthyroidism	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Endocrine disorders Hypothyroidism	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Eye disorders Vision blurred	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Abdominal pain upper	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Ascites	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Colitis	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Constipation	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	66.7% 2/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Nausea	60.0% 3/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Oral discomfort	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Presbyoesophagus	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Stomatitis	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Toothache	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Gastrointestinal disorders Vomiting	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Administration site reaction	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Asthenia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Chills	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Fatigue	60.0% 3/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	100.0% 3/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Influenza like illness	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Localised oedema	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Malaise	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Mucosal inflammation	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Oedema peripheral	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
General disorders Pyrexia	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Bronchitis	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Candida infection	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Ear infection	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Fungal skin infection	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Gastroenteritis viral	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Hordeolum	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Otitis media	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Pneumonia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Sinusitis	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Upper respiratory tract infection	60.0% 3/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Urinary tract infection	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Infections and infestations Viral upper respiratory tract infection	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Injury, poisoning and procedural complications Fall	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Injury, poisoning and procedural complications Fracture	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Injury, poisoning and procedural complications Infusion related reaction	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Injury, poisoning and procedural complications Wound	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Alanine aminotransferase increased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Blood creatinine increased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Lymphocyte count decreased	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Platelet count decreased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations Weight decreased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Investigations White blood cell count decreased	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Decreased appetite	60.0% 3/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	44.4% 4/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hypomagnesaemia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hyponatraemia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Metabolism and nutrition disorders Malnutrition	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Myalgia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Balance disorder	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Cognitive disorder	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Dizziness	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Dysgeusia	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Headache	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Lethargy	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Memory impairment	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Migraine	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Peripheral motor neuropathy	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Product Issues Device breakage	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Psychiatric disorders Depression	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Psychiatric disorders Insomnia	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Renal and urinary disorders Dysuria	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Renal and urinary disorders Hydronephrosis	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Reproductive system and breast disorders Breast tenderness	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Reproductive system and breast disorders Pruritus genital	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	100.0% 3/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	44.4% 4/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Epistaxis	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Haemoptysis	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	22.2% 2/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Sinus congestion	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Dry skin	40.0% 2/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Eczema	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Erythema	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Hair texture abnormal	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	44.4% 4/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 3/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Rash maculo-papular	60.0% 3/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	66.7% 2/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	33.3% 1/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	11.1% 1/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months
Vascular disorders Jugular vein thrombosis	20.0% 1/5 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/3 • Baseline up to 90 days after the last dose of study drug, approximately 27 months	0.00% 0/9 • Baseline up to 90 days after the last dose of study drug, approximately 27 months

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER