Trial Outcomes & Findings for A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors (NCT NCT00557856)

Last Updated: 2015-10-19

Results Overview

MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

70 participants

Primary outcome timeframe

Baseline up to 42 days after the start of each increased treatment dose

Results posted on

2015-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	PF-03446962 0.5 mg/kg: Part 1 PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Part 1: Dose Escalation Phase STARTED	7	5	6	3	4	8	7	6	0
Part 1: Dose Escalation Phase Treated	5	5	6	3	4	8	7	6	0
Part 1: Dose Escalation Phase COMPLETED	0	0	0	0	0	0	0	0	0
Part 1: Dose Escalation Phase NOT COMPLETED	7	5	6	3	4	8	7	6	0
Part 2: Exploratory Phase STARTED	0	0	0	0	0	0	0	0	24
Part 2: Exploratory Phase COMPLETED	0	0	0	0	0	0	0	0	0
Part 2: Exploratory Phase NOT COMPLETED	0	0	0	0	0	0	0	0	24

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-03446962 0.5 mg/kg: Part 1 PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Part 1: Dose Escalation Phase objective progression or relapse	3	5	3	1	3	2	5	3	0
Part 1: Dose Escalation Phase Withdrawal by Subject	1	0	1	0	0	0	0	0	0
Part 1: Dose Escalation Phase Adverse Event	1	0	1	1	1	3	1	2	0
Part 1: Dose Escalation Phase Other	0	0	1	1	0	0	0	1	0
Part 1: Dose Escalation Phase Death	0	0	0	0	0	1	0	0	0
Part 1: Dose Escalation Phase global deterioration of health status	0	0	0	0	0	2	1	0	0
Part 1: Dose Escalation Phase randomized but not treated	2	0	0	0	0	0	0	0	0
Part 2: Exploratory Phase objective progression or relapse	0	0	0	0	0	0	0	0	15
Part 2: Exploratory Phase Withdrawal by Subject	0	0	0	0	0	0	0	0	1
Part 2: Exploratory Phase Adverse Event	0	0	0	0	0	0	0	0	4
Part 2: Exploratory Phase Other	0	0	0	0	0	0	0	0	1
Part 2: Exploratory Phase Death	0	0	0	0	0	0	0	0	2
Part 2: Exploratory Phase global deterioration of health status	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-03446962 n=68 Participants All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \[mg/kg\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
Age, Continuous	61.3 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 42 days after the start of each increased treatment dose

Population: The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=44 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Maximum Tolerated Dose (MTD): Part 1	—	10.0 milligram/kilogram (mg/kg)	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 42 days after the start of each increased treatment dose

Population: The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.

RP2D was defined as the lower dose level to MTD based on the safety profile.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=44 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Recommended Phase 2 Dose (RP2D): Part 1	—	7.0 mg/kg	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 of Day 1 up to 28 days after the last dose of treatment

Population: Safety population included all enrolled participants who received at least one dose of study drug.

An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 Treatment-related	20 participants	4 participants	2 participants	4 participants	1 participants	3 participants	7 participants	6 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 All causalities	24 participants	5 participants	5 participants	6 participants	3 participants	4 participants	8 participants	7 participants	6 participants

SECONDARY outcome

Timeframe: Cycle 1 of Day 1 up to 28 days after the last dose of treatment

Population: Safety population included all enrolled participants who received at least one dose of study drug.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 Grade 1	3 participants	3 participants	2 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 Grade 2	7 participants	1 participants	3 participants	1 participants	1 participants	4 participants	3 participants	3 participants	1 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 Grade 3	9 participants	0 participants	0 participants	4 participants	1 participants	0 participants	2 participants	3 participants	3 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 Grade 4	4 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 Grade 5	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Cycle 1 of Day 1 up to 28 days after the last dose of treatment

Population: Safety population included all enrolled participants who received at least one dose of study drug.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 Serious Adverse Events	9 participants	2 participants	0 participants	3 participants	0 participants	1 participants	4 participants	2 participants	3 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 Non-Serious Adverse Events	24 participants	5 participants	5 participants	6 participants	3 participants	4 participants	8 participants	7 participants	6 participants

SECONDARY outcome

Timeframe: Cycle 1 of Day 1 up to 28 days after the last dose of treatment

Population: Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.

Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 of Day 1 up to 28 days after the last dose of treatment

Population: Safety population included all enrolled participants who received at least one dose of study drug.

Laboratory tests included hematology (hemoglobin, lymphocytes absolute \[abs\], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute \[NCI\] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 \[mild AE: did not cause any significant problem, no dose adjustment required\]; grade 2 \[moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event\]; grade 3 \[severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event\] and grade 4 \[life threatening AE\]). Overall data of the 4 grades is reported.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=7 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypoglycemia	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hemoglobin	20 participants	4 participants	4 participants	5 participants	1 participants	3 participants	5 participants	4 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Lymphocytes abs	12 participants	4 participants	4 participants	4 participants	1 participants	2 participants	4 participants	2 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Neutrophils abs	3 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Platelets	12 participants	1 participants	1 participants	2 participants	2 participants	1 participants	2 participants	3 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 White blood cells	4 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Alanine Aminotransferase	18 participants	1 participants	0 participants	0 participants	1 participants	1 participants	3 participants	2 participants	5 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Alkaline Phosphatase	20 participants	1 participants	3 participants	4 participants	0 participants	3 participants	4 participants	6 participants	6 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Amylase	6 participants	0 participants	1 participants	3 participants	1 participants	2 participants	2 participants	2 participants	1 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Aspartate Aminotransferase	20 participants	0 participants	0 participants	1 participants	1 participants	2 participants	2 participants	5 participants	5 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Bilirubin	11 participants	0 participants	0 participants	2 participants	1 participants	0 participants	2 participants	2 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Creatinine	10 participants	1 participants	2 participants	0 participants	2 participants	1 participants	2 participants	3 participants	5 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypercalcemia	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hyperglycemia	23 participants	4 participants	3 participants	6 participants	1 participants	4 participants	5 participants	5 participants	4 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hyperkalemia	5 participants	0 participants	0 participants	1 participants	1 participants	0 participants	1 participants	3 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypernatremia	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypoalbuminemia	12 participants	1 participants	0 participants	2 participants	0 participants	2 participants	4 participants	3 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypocalcemia	6 participants	1 participants	0 participants	1 participants	0 participants	0 participants	1 participants	3 participants	2 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypokalemia	7 participants	2 participants	0 participants	1 participants	0 participants	2 participants	3 participants	0 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hyponatremia	17 participants	1 participants	1 participants	2 participants	2 participants	2 participants	5 participants	6 participants	5 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Hypophosphatemia	10 participants	1 participants	1 participants	2 participants	1 participants	0 participants	1 participants	2 participants	0 participants
Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 Lipase	7 participants	1 participants	1 participants	2 participants	1 participants	1 participants	0 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490

Population: Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as \>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Percentage of Participants With Objective Response: Part 1 and Part 2	0 percentage of participants Interval 0.0 to 11.7	0 percentage of participants Interval 0.0 to 45.1	0 percentage of participants Interval 0.0 to 45.1	16.7 percentage of participants Interval 0.9 to 58.2	0 percentage of participants Interval 0.0 to 63.2	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 31.2	28.6 percentage of participants Interval 5.3 to 65.9	0 percentage of participants Interval 0.0 to 39.3

SECONDARY outcome

Timeframe: Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490

Population: Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.

Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: \>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=24 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Percentage of Participants With Disease Control: Part 2	—	29.2 percentage of participants Interval 14.6 to 47.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490

Population: Safety population included all participants who received at least one dose of study drug.

Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\] per RECIST). PD: \>=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=24 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Time To Progression (TTP): Part 2	—	3.0 months Interval 1.4 to 4.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)

Population: Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=7 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=4 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=1 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=2 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=3 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=3 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=3 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Volume of Distribution: Part 1 and Part 2	6.110 liter (L) Standard Deviation 1.6303	6.350 liter (L) Standard Deviation 1.1399	5.770 liter (L) Standard Deviation 1.1850	7.421 liter (L) Standard Deviation 2.8525	NA liter (L) Standard Deviation NA Data was not summarized since only 1 participant had reportable value, as per planned analysis.	NA liter (L) Standard Deviation NA Data was not summarized since only 2 participants had reportable value, as per planned analysis.	6.718 liter (L) Standard Deviation 1.2400	5.373 liter (L) Standard Deviation 0.85541	6.675 liter (L) Standard Deviation 2.4858

OTHER_PRE_SPECIFIED outcome

Population: Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2	153100 nanogram/milliliter (ng/mL) Standard Deviation 60116	7210 nanogram/milliliter (ng/mL) Standard Deviation 2004.0	18510 nanogram/milliliter (ng/mL) Standard Deviation 5623.4	38090 nanogram/milliliter (ng/mL) Standard Deviation 20361	62530 nanogram/milliliter (ng/mL) Standard Deviation 25484	123700 nanogram/milliliter (ng/mL) Standard Deviation 49961	140600 nanogram/milliliter (ng/mL) Standard Deviation 49562	274500 nanogram/milliliter (ng/mL) Standard Deviation 102100	304000 nanogram/milliliter (ng/mL) Standard Deviation 131350

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=15 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=3 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=2 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=5 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=5 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=2 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 12 Day 1 (n=0, 0, 0, 0, 1, 2, 1, 0, 2)	69200 ng/mL Standard Deviation 71842	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	64500 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	52100 ng/mL Standard Deviation 7636.8	222000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 11 Day 1 (n=0, 0, 0, 1, 1, 2, 1, 0, 3)	103600 ng/mL Standard Deviation 78883	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	44200 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	40500 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	55050 ng/mL Standard Deviation 10677	186000 ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 2 Day 1 (n=3, 2, 6, 3, 4, 5, 5, 2, 15)	17230 ng/mL Standard Deviation 8815.0	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	1010 ng/mL Standard Deviation 1377.1	4473 ng/mL Standard Deviation 1888.6	8675 ng/mL Standard Deviation 2203.0	14820 ng/mL Standard Deviation 4943.4	33440 ng/mL Standard Deviation 14738	35450 ng/mL Standard Deviation 1060.7
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 3 Day 1 (n=3, 2, 4, 3, 1, 4, 3, 1, 13)	40870 ng/mL Standard Deviation 25784	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	704.0 ng/mL Standard Deviation 461.03	9992 ng/mL Standard Deviation 14932	17070 ng/mL Standard Deviation 5122.8	4850 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	45850 ng/mL Standard Deviation 15660	77530 ng/mL Standard Deviation 31351	69400 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 4 Day 1 (n=2, 2, 2, 3, 1, 4, 3, 1, 12)	64960 ng/mL Standard Deviation 35284	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	2000 ng/mL Standard Deviation 353.55	6715 ng/mL Standard Deviation 2934.5	22030 ng/mL Standard Deviation 3931.1	32700 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	41880 ng/mL Standard Deviation 3108.5	93130 ng/mL Standard Deviation 44384	87100 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 5 Day 1 (n= 1, 0, 2, 3, 1, 3, 3, 1, 12)	76960 ng/mL Standard Deviation 40711	588.0 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	11490 ng/mL Standard Deviation 3691.1	25930 ng/mL Standard Deviation 5488.5	42200 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	51600 ng/mL Standard Deviation 12065	103300 ng/mL Standard Deviation 56589	98800 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 6 Day 1 (n=0, 2, 2, 1, 1, 1, 1, 0, 7)	69250 ng/mL Standard Deviation 52222	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	13470 ng/mL Standard Deviation 6554.9	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	45000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	58070 ng/mL Standard Deviation 8471.9	44700 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 7 Day 1 (n=0, 0, 2, 1, 1, 3, 1, 0, 7)	68100 ng/mL Standard Deviation 56580	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	11920 ng/mL Standard Deviation 7749.9	34200 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	45000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	73670 ng/mL Standard Deviation 24393	44700 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 8 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 5)	99740 ng/mL Standard Deviation 66263	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	10850 ng/mL Standard Deviation 353.55	43400 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	45100 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	76950 ng/mL Standard Deviation 42497	217000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 9 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 4)	85750 ng/mL Standard Deviation 57225	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	14150 ng/mL Standard Deviation 1626.3	47500 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	55200 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	55150 ng/mL Standard Deviation 11526	294000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.
Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 Cycle 10 Day 1 (n=0, 0, 1, 1, 1, 2, 1, 0, 3)	66620 ng/mL Standard Deviation 50809	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.	20100 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	43200 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	39000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	59050 ng/mL Standard Deviation 16334	190000 ng/mL Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA ng/mL Standard Deviation NA Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.

OTHER_PRE_SPECIFIED outcome

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=7 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=5 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2	1.77 hour Interval 0.9 to 215.0	1.50 hour Interval 1.0 to 2.0	1.58 hour Interval 1.0 to 2.0	1.75 hour Interval 0.917 to 2.5	1.50 hour Interval 1.0 to 2.0	1.99 hour Interval 1.0 to 3.75	1.75 hour Interval 1.17 to 5.0	1.50 hour Interval 0.517 to 5.0	3.34 hour Interval 1.0 to 24.0

OTHER_PRE_SPECIFIED outcome

AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=7 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=5 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2	22890000 nanogramhour/milliliter (nghr/mL) Standard Deviation 10395000	490000 nanogramhour/milliliter (nghr/mL) Standard Deviation 132220	1752000 nanogramhour/milliliter (nghr/mL) Standard Deviation 436440	3281000 nanogramhour/milliliter (nghr/mL) Standard Deviation 1817700	8247000 nanogramhour/milliliter (nghr/mL) Standard Deviation 2657400	15070000 nanogramhour/milliliter (nghr/mL) Standard Deviation 1447700	22890000 nanogramhour/milliliter (nghr/mL) Standard Deviation 7372200	45750000 nanogramhour/milliliter (nghr/mL) Standard Deviation 15972000	52660000 nanogramhour/milliliter (nghr/mL) Standard Deviation 29315000

OTHER_PRE_SPECIFIED outcome

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=7 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=5 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2	22850000 ng*hr/mL Standard Deviation 10504000	471400 ng*hr/mL Standard Deviation 124340	1683000 ng*hr/mL Standard Deviation 435490	3273000 ng*hr/mL Standard Deviation 1819200	8247000 ng*hr/mL Standard Deviation 2657400	15690000 ng*hr/mL Standard Deviation 2965800	21380000 ng*hr/mL Standard Deviation 7823700	44110000 ng*hr/mL Standard Deviation 15577000	51160000 ng*hr/mL Standard Deviation 21718000

OTHER_PRE_SPECIFIED outcome

CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=7 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=4 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=1 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=2 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=3 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=3 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=3 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Systemic Clearance(CL): Part 1 and Part 2	0.01921 liter/hour (L/hr) Standard Deviation 0.00507	0.07675 liter/hour (L/hr) Standard Deviation 0.02318	0.03469 liter/hour (L/hr) Standard Deviation 0.00866	0.04198 liter/hour (L/hr) Standard Deviation 0.03927	NA liter/hour (L/hr) Standard Deviation NA Data was not summarized since only 1 participant had reportable value, as per planned analysis.	NA liter/hour (L/hr) Standard Deviation NA Data was not summarized since only 2 participants had reportable value, as per planned analysis.	0.01861 liter/hour (L/hr) Standard Deviation 0.00225	0.01668 liter/hour (L/hr) Standard Deviation 0.00482	0.01169 liter/hour (L/hr) Standard Deviation 0.01288

OTHER_PRE_SPECIFIED outcome

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=7 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=4 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=1 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=2 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=3 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=3 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=3 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Plasma Decay Half-Life (t1/2): Part 1 and Part 2	9.616 hours Standard Deviation 2.3870	2.678 hours Standard Deviation 1.0622	5.588 hours Standard Deviation 2.3790	7.360 hours Standard Deviation 4.5596	NA hours Standard Deviation NA Data was not summarized since only 1 participant had reportable value, as per planned analysis.	NA hours Standard Deviation NA Data was not summarized since only 2 participants had reportable value, as per planned analysis.	11.90 hours Standard Deviation 0.88882	10.22 hours Standard Deviation 2.3394	17.77 hours Standard Deviation 5.6589

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 3 months after last dose

Population: Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.

HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (\>=4.32).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Population: Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.

Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C3D1: CCL2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)	791.3 picogram/milliliter (pg/mL) Standard Deviation 364.58	1413.8 picogram/milliliter (pg/mL) Standard Deviation 651.34	933.3 picogram/milliliter (pg/mL) Standard Deviation 259.79	951.0 picogram/milliliter (pg/mL) Standard Deviation 418.52	793.2 picogram/milliliter (pg/mL) Standard Deviation 180.32	735.7 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	818.3 picogram/milliliter (pg/mL) Standard Deviation 422.89	909.9 picogram/milliliter (pg/mL) Standard Deviation 278.50	617.1 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 Baseline: Ang-2 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)	1497.4 picogram/milliliter (pg/mL) Standard Deviation 881.71	280.9 picogram/milliliter (pg/mL) Standard Deviation 107.01	245.2 picogram/milliliter (pg/mL) Standard Deviation 85.36	405.3 picogram/milliliter (pg/mL) Standard Deviation 171.82	233.8 picogram/milliliter (pg/mL) Standard Deviation 47.89	554.3 picogram/milliliter (pg/mL) Standard Deviation 404.80	629.7 picogram/milliliter (pg/mL) Standard Deviation 265.33	566.3 picogram/milliliter (pg/mL) Standard Deviation 617.76	600.5 picogram/milliliter (pg/mL) Standard Deviation 469.09
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C3D1: Ang-2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)	1539.3 picogram/milliliter (pg/mL) Standard Deviation 1036.24	309.1 picogram/milliliter (pg/mL) Standard Deviation 133.43	338.1 picogram/milliliter (pg/mL) Standard Deviation 235.11	417.6 picogram/milliliter (pg/mL) Standard Deviation 192.35	258.3 picogram/milliliter (pg/mL) Standard Deviation 57.44	501.3 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	510.0 picogram/milliliter (pg/mL) Standard Deviation 305.51	254.5 picogram/milliliter (pg/mL) Standard Deviation 44.89	586.8 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D16H: Ang-2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)	1509.6 picogram/milliliter (pg/mL) Standard Deviation 813.06	357.7 picogram/milliliter (pg/mL) Standard Deviation 87.87	326.0 picogram/milliliter (pg/mL) Standard Deviation 122.58	410.2 picogram/milliliter (pg/mL) Standard Deviation 170.55	266.3 picogram/milliliter (pg/mL) Standard Deviation 28.31	580.3 picogram/milliliter (pg/mL) Standard Deviation 485.49	558.0 picogram/milliliter (pg/mL) Standard Deviation 249.90	498.4 picogram/milliliter (pg/mL) Standard Deviation 508.76	548.1 picogram/milliliter (pg/mL) Standard Deviation 324.70
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D22: Ang-2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)	1651.4 picogram/milliliter (pg/mL) Standard Deviation 894.33	297.0 picogram/milliliter (pg/mL) Standard Deviation 146.98	429.8 picogram/milliliter (pg/mL) Standard Deviation 202.03	489.7 picogram/milliliter (pg/mL) Standard Deviation 235.28	248.0 picogram/milliliter (pg/mL) Standard Deviation 84.73	725.2 picogram/milliliter (pg/mL) Standard Deviation 654.99	491.8 picogram/milliliter (pg/mL) Standard Deviation 236.61	613.0 picogram/milliliter (pg/mL) Standard Deviation 627.25	400.0 picogram/milliliter (pg/mL) Standard Deviation 198.85
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C2D1: Ang-2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)	1473.5 picogram/milliliter (pg/mL) Standard Deviation 690.55	304.4 picogram/milliliter (pg/mL) Standard Deviation 126.39	312.4 picogram/milliliter (pg/mL) Standard Deviation 195.37	501.2 picogram/milliliter (pg/mL) Standard Deviation 194.40	205.7 picogram/milliliter (pg/mL) Standard Deviation 48.10	637.5 picogram/milliliter (pg/mL) Standard Deviation 535.52	445.3 picogram/milliliter (pg/mL) Standard Deviation 231.91	557.9 picogram/milliliter (pg/mL) Standard Deviation 575.66	338.1 picogram/milliliter (pg/mL) Standard Deviation 84.57
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C2D1: BMP-9 (n=3, 2, 6, 2, 4, 4, 5, 2, 20)	40.0 picogram/milliliter (pg/mL) Standard Deviation 51.36	47.5 picogram/milliliter (pg/mL) Standard Deviation 52.77	23.9 picogram/milliliter (pg/mL) Standard Deviation 0.49	54.7 picogram/milliliter (pg/mL) Standard Deviation 112.92	18.2 picogram/milliliter (pg/mL) Standard Deviation 0.28	58.9 picogram/milliliter (pg/mL) Standard Deviation 85.35	391.7 picogram/milliliter (pg/mL) Standard Deviation 755.57	26.5 picogram/milliliter (pg/mL) Standard Deviation 16.89	12.2 picogram/milliliter (pg/mL) Standard Deviation 4.88
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C3D1: BMP-9 (n=2, 2, 4, 2, 1, 3, 3, 1, 12)	40.8 picogram/milliliter (pg/mL) Standard Deviation 36.65	80.4 picogram/milliliter (pg/mL) Standard Deviation 86.41	21.3 picogram/milliliter (pg/mL) Standard Deviation 2.76	99.4 picogram/milliliter (pg/mL) Standard Deviation 176.84	18.8 picogram/milliliter (pg/mL) Standard Deviation 0.00	10.8 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	933.3 picogram/milliliter (pg/mL) Standard Deviation 1593.69	32.2 picogram/milliliter (pg/mL) Standard Deviation 13.14	16.6 picogram/milliliter (pg/mL) Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 EOT: BMP-9 (n=5, 5, 2, 2, 4, 4, 5, 5, 17)	33.8 picogram/milliliter (pg/mL) Standard Deviation 27.55	53.2 picogram/milliliter (pg/mL) Standard Deviation 70.27	15.5 picogram/milliliter (pg/mL) Standard Deviation 5.86	156.4 picogram/milliliter (pg/mL) Standard Deviation 179.39	16.5 picogram/milliliter (pg/mL) Standard Deviation 2.33	75.5 picogram/milliliter (pg/mL) Standard Deviation 94.07	246.1 picogram/milliliter (pg/mL) Standard Deviation 460.69	44.0 picogram/milliliter (pg/mL) Standard Deviation 35.00	17.1 picogram/milliliter (pg/mL) Standard Deviation 7.69
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 Baseline: CCL2 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)	1743.1 picogram/milliliter (pg/mL) Standard Deviation 1267.52	1048.4 picogram/milliliter (pg/mL) Standard Deviation 259.96	897.1 picogram/milliliter (pg/mL) Standard Deviation 414.25	1296.3 picogram/milliliter (pg/mL) Standard Deviation 629.37	1179.8 picogram/milliliter (pg/mL) Standard Deviation 597.43	858.5 picogram/milliliter (pg/mL) Standard Deviation 697.41	1648.5 picogram/milliliter (pg/mL) Standard Deviation 744.80	1798.7 picogram/milliliter (pg/mL) Standard Deviation 1374.40	2659.5 picogram/milliliter (pg/mL) Standard Deviation 1356.79
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 EOT: Ang-2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)	2791.2 picogram/milliliter (pg/mL) Standard Deviation 3637.55	507.2 picogram/milliliter (pg/mL) Standard Deviation 375.16	355.6 picogram/milliliter (pg/mL) Standard Deviation 166.32	439.5 picogram/milliliter (pg/mL) Standard Deviation 292.25	346.7 picogram/milliliter (pg/mL) Standard Deviation 57.94	775.6 picogram/milliliter (pg/mL) Standard Deviation 618.41	499.8 picogram/milliliter (pg/mL) Standard Deviation 368.96	974.9 picogram/milliliter (pg/mL) Standard Deviation 1014.67	737.9 picogram/milliliter (pg/mL) Standard Deviation 572.30
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 Baseline: BMP-9 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)	47.6 picogram/milliliter (pg/mL) Standard Deviation 50.88	41.7 picogram/milliliter (pg/mL) Standard Deviation 44.60	18.3 picogram/milliliter (pg/mL) Standard Deviation 6.92	67.2 picogram/milliliter (pg/mL) Standard Deviation 114.87	18.4 picogram/milliliter (pg/mL) Standard Deviation 11.54	68.2 picogram/milliliter (pg/mL) Standard Deviation 79.58	262.0 picogram/milliliter (pg/mL) Standard Deviation 669.08	48.9 picogram/milliliter (pg/mL) Standard Deviation 23.13	29.0 picogram/milliliter (pg/mL) Standard Deviation 11.38
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D16H: BMP-9 (n=4, 3, 6, 2, 4, 7, 7, 6, 23)	45.0 picogram/milliliter (pg/mL) Standard Deviation 48.97	55.3 picogram/milliliter (pg/mL) Standard Deviation 66.60	19.5 picogram/milliliter (pg/mL) Standard Deviation 10.38	56.4 picogram/milliliter (pg/mL) Standard Deviation 104.06	20.9 picogram/milliliter (pg/mL) Standard Deviation 10.39	54.1 picogram/milliliter (pg/mL) Standard Deviation 58.18	273.3 picogram/milliliter (pg/mL) Standard Deviation 658.58	35.6 picogram/milliliter (pg/mL) Standard Deviation 25.63	14.0 picogram/milliliter (pg/mL) Standard Deviation 5.99
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D22: BMP-9 (n=4, 5, 6, 2, 4, 5, 7, 5, 19)	39.2 picogram/milliliter (pg/mL) Standard Deviation 40.88	45.7 picogram/milliliter (pg/mL) Standard Deviation 51.45	16.7 picogram/milliliter (pg/mL) Standard Deviation 7.57	60.5 picogram/milliliter (pg/mL) Standard Deviation 121.98	17.1 picogram/milliliter (pg/mL) Standard Deviation 9.90	35.7 picogram/milliliter (pg/mL) Standard Deviation 36.66	394.0 picogram/milliliter (pg/mL) Standard Deviation 852.68	33.0 picogram/milliliter (pg/mL) Standard Deviation 20.44	22.0 picogram/milliliter (pg/mL) Standard Deviation 12.27
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D16H: CCL2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)	887.7 picogram/milliliter (pg/mL) Standard Deviation 411.38	1413.1 picogram/milliliter (pg/mL) Standard Deviation 451.52	868.2 picogram/milliliter (pg/mL) Standard Deviation 348.23	1019.8 picogram/milliliter (pg/mL) Standard Deviation 222.52	845.5 picogram/milliliter (pg/mL) Standard Deviation 309.44	746.4 picogram/milliliter (pg/mL) Standard Deviation 330.31	910.1 picogram/milliliter (pg/mL) Standard Deviation 297.10	1176.7 picogram/milliliter (pg/mL) Standard Deviation 198.86	1253.9 picogram/milliliter (pg/mL) Standard Deviation 353.28
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C1D22: CCL2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)	846.5 picogram/milliliter (pg/mL) Standard Deviation 524.84	1300.7 picogram/milliliter (pg/mL) Standard Deviation 519.44	882.1 picogram/milliliter (pg/mL) Standard Deviation 300.21	1065.6 picogram/milliliter (pg/mL) Standard Deviation 491.41	898.4 picogram/milliliter (pg/mL) Standard Deviation 144.11	801.0 picogram/milliliter (pg/mL) Standard Deviation 432.10	896.0 picogram/milliliter (pg/mL) Standard Deviation 365.37	1146.9 picogram/milliliter (pg/mL) Standard Deviation 400.30	1061.8 picogram/milliliter (pg/mL) Standard Deviation 469.42
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 C2D1: CCL2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)	801.9 picogram/milliliter (pg/mL) Standard Deviation 338.56	1466.4 picogram/milliliter (pg/mL) Standard Deviation 510.75	1156.6 picogram/milliliter (pg/mL) Standard Deviation 493.42	1091.0 picogram/milliliter (pg/mL) Standard Deviation 317.65	777.6 picogram/milliliter (pg/mL) Standard Deviation 220.42	692.5 picogram/milliliter (pg/mL) Standard Deviation 216.16	1206.5 picogram/milliliter (pg/mL) Standard Deviation 443.00	858.6 picogram/milliliter (pg/mL) Standard Deviation 165.26	1060.8 picogram/milliliter (pg/mL) Standard Deviation 577.85
Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 EOT: CCL2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)	743.7 picogram/milliliter (pg/mL) Standard Deviation 314.64	1132.1 picogram/milliliter (pg/mL) Standard Deviation 202.68	898.5 picogram/milliliter (pg/mL) Standard Deviation 270.19	729.7 picogram/milliliter (pg/mL) Standard Deviation 242.18	645.4 picogram/milliliter (pg/mL) Standard Deviation 94.59	699.6 picogram/milliliter (pg/mL) Standard Deviation 372.50	1190.4 picogram/milliliter (pg/mL) Standard Deviation 675.67	1176.2 picogram/milliliter (pg/mL) Standard Deviation 699.03	1179.9 picogram/milliliter (pg/mL) Standard Deviation 370.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C2D1: CD54 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	980791 pg/ml Standard Deviation 354159	433203 pg/ml Standard Deviation 90282.8	841543 pg/ml Standard Deviation 568591	585420 pg/ml Standard Deviation 308551	375141 pg/ml Standard Deviation 32483.6	628011 pg/ml Standard Deviation 242437	575469 pg/ml Standard Deviation 392901	641992 pg/ml Standard Deviation 351793	727099 pg/ml Standard Deviation 302728
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C3D1: CD54 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	969068 pg/ml Standard Deviation 433245	495252 pg/ml Standard Deviation 112929	566407 pg/ml Standard Deviation 160088	646360 pg/ml Standard Deviation 390594	474589 pg/ml Standard Deviation 70371.2	605375 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	664537 pg/ml Standard Deviation 533228	414291 pg/ml Standard Deviation 147170	890980 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D22: Endoglin (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)	36010.7 pg/ml Standard Deviation 7362.59	25412.5 pg/ml Standard Deviation 2910.37	30123.0 pg/ml Standard Deviation 2225.81	27615.3 pg/ml Standard Deviation 9426.55	32203.6 pg/ml Standard Deviation 5574.70	26231.6 pg/ml Standard Deviation 3899.05	29895.0 pg/ml Standard Deviation 2248.59	33397.7 pg/ml Standard Deviation 13366.3	24970.6 pg/ml Standard Deviation 7020.96
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D16H: Endoglin (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	33976.7 pg/ml Standard Deviation 9156.44	24961.0 pg/ml Standard Deviation 2310.44	24983.9 pg/ml Standard Deviation 5489.16	21789.5 pg/ml Standard Deviation 3978.18	31365.1 pg/ml Standard Deviation 3547.94	25209.2 pg/ml Standard Deviation 3357.89	24336.6 pg/ml Standard Deviation 3196.96	25110.6 pg/ml Standard Deviation 8066.23	26774.1 pg/ml Standard Deviation 11443.0
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 Baseline: CD106 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	4618397 pg/ml Standard Deviation 2077485	1426995 pg/ml Standard Deviation 59227.1	1977059 pg/ml Standard Deviation 278968	2103430 pg/ml Standard Deviation 918193	1550000 pg/ml Standard Deviation 637320	2317802 pg/ml Standard Deviation 1217870	2537306 pg/ml Standard Deviation 1097384	1994549 pg/ml Standard Deviation 1151754	2380621 pg/ml Standard Deviation 1221978
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D16H: CD106 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	4441245 pg/ml Standard Deviation 2178832	1553640 pg/ml Standard Deviation 248023	1751998 pg/ml Standard Deviation 131286	1997949 pg/ml Standard Deviation 699820	1409035 pg/ml Standard Deviation 308143	2058998 pg/ml Standard Deviation 1253058	2121253 pg/ml Standard Deviation 675955	1825721 pg/ml Standard Deviation 1290987	2105192 pg/ml Standard Deviation 1365510
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D22: CD106 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)	5453614 pg/ml Standard Deviation 2116043	1531678 pg/ml Standard Deviation 249394	2134392 pg/ml Standard Deviation 357871	2251447 pg/ml Standard Deviation 517132	1370676 pg/ml Standard Deviation 329573	2817598 pg/ml Standard Deviation 2026342	2762433 pg/ml Standard Deviation 1722911	2701837 pg/ml Standard Deviation 1710834	2456276 pg/ml Standard Deviation 1404983
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C2D1: CD106 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	5217619 pg/ml Standard Deviation 2747474	1577290 pg/ml Standard Deviation 378509	1799035 pg/ml Standard Deviation 695018	2229424 pg/ml Standard Deviation 469152	1269574 pg/ml Standard Deviation 366430	2370883 pg/ml Standard Deviation 1278663	2542120 pg/ml Standard Deviation 2147151	1676349 pg/ml Standard Deviation 691658	3247890 pg/ml Standard Deviation 1683551
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C3D1: CD106 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	4482748 pg/ml Standard Deviation 2376204	1508775 pg/ml Standard Deviation 201658	1994588 pg/ml Standard Deviation 266837	2465890 pg/ml Standard Deviation 1070226	1892928 pg/ml Standard Deviation 571192	2162501 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	3009982 pg/ml Standard Deviation 2128505	1380137 pg/ml Standard Deviation 234263	4814239 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 EOT: CD106 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	6321592 pg/ml Standard Deviation 2385497	2097201 pg/ml Standard Deviation 582243	1782709 pg/ml Standard Deviation 473363	3480129 pg/ml Standard Deviation 1753142	1600889 pg/ml Standard Deviation 484412	3004218 pg/ml Standard Deviation 2225879	2169361 pg/ml Standard Deviation 755936	3869570 pg/ml Standard Deviation 2242247	2600730 pg/ml Standard Deviation 1098325
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 Baseline: CD54 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	925590 pg/ml Standard Deviation 408338	456653 pg/ml Standard Deviation 100191	592276 pg/ml Standard Deviation 164098	598761 pg/ml Standard Deviation 333166	703255 pg/ml Standard Deviation 486462	590523 pg/ml Standard Deviation 144561	567736 pg/ml Standard Deviation 306989	627494 pg/ml Standard Deviation 279501	554785 pg/ml Standard Deviation 201270
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C2D1: Endoglin (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	37263.6 pg/ml Standard Deviation 9744.94	22204.3 pg/ml Standard Deviation 1736.96	32984.2 pg/ml Standard Deviation 691.27	23247.5 pg/ml Standard Deviation 5843.99	27246.9 pg/ml Standard Deviation 4925.02	28478.7 pg/ml Standard Deviation 5527.04	24736.3 pg/ml Standard Deviation 5716.80	27295.5 pg/ml Standard Deviation 8538.87	27813.5 pg/ml Standard Deviation 15243.7
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C3D1: Endoglin (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	35347.9 pg/ml Standard Deviation 6702.15	24503.9 pg/ml Standard Deviation 3500.18	29688.2 pg/ml Standard Deviation 2138.72	24944.4 pg/ml Standard Deviation 2436.94	31266.8 pg/ml Standard Deviation 3466.76	22233.2 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	24395.8 pg/ml Standard Deviation 2414.67	24540.0 pg/ml Standard Deviation 4547.98	33259.2 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 EOT: Endoglin (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	35726.0 pg/ml Standard Deviation 8159.01	28268.0 pg/ml Standard Deviation 7727.06	26852.1 pg/ml Standard Deviation 6037.41	23453.9 pg/ml Standard Deviation 3631.56	28064.5 pg/ml Standard Deviation 4097.50	28094.3 pg/ml Standard Deviation 1554.41	29350.8 pg/ml Standard Deviation 2213.84	38234.3 pg/ml Standard Deviation 16532.0	26855.9 pg/ml Standard Deviation 4711.30
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D16H: CD54 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	1053926 pg/ml Standard Deviation 491420	458194 pg/ml Standard Deviation 64789.1	512402 pg/ml Standard Deviation 81155.7	624061 pg/ml Standard Deviation 233499	450887 pg/ml Standard Deviation 168300	538807 pg/ml Standard Deviation 172168	548456 pg/ml Standard Deviation 201218	603467 pg/ml Standard Deviation 311056	517460 pg/ml Standard Deviation 251249
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 C1D22: CD54 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)	1173444 pg/ml Standard Deviation 546999	428766 pg/ml Standard Deviation 80302.4	585405 pg/ml Standard Deviation 46397.3	578775 pg/ml Standard Deviation 246897	356495 pg/ml Standard Deviation 54530.0	565451 pg/ml Standard Deviation 196841	612504 pg/ml Standard Deviation 370207	939357 pg/ml Standard Deviation 706017	604023 pg/ml Standard Deviation 291355
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 EOT: CD54 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	1108796 pg/ml Standard Deviation 416355	535193 pg/ml Standard Deviation 116435	504828 pg/ml Standard Deviation 53486.9	1022507 pg/ml Standard Deviation 841417	483216 pg/ml Standard Deviation 158483	600281 pg/ml Standard Deviation 94835.6	537001 pg/ml Standard Deviation 171132	1096693 pg/ml Standard Deviation 941040	569412 pg/ml Standard Deviation 121592
Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2 Baseline: Endoglin (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	32680.3 pg/ml Standard Deviation 6820.09	24345.9 pg/ml Standard Deviation 1067.46	28133.0 pg/ml Standard Deviation 5202.28	22355.2 pg/ml Standard Deviation 5984.52	30265.3 pg/ml Standard Deviation 2727.69	26342.4 pg/ml Standard Deviation 2922.41	24864.6 pg/ml Standard Deviation 3830.51	26313.7 pg/ml Standard Deviation 6449.03	25599.5 pg/ml Standard Deviation 7530.00

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=6 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=5 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C3D1: TGFb1 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)	73118.3 pg/ml Standard Deviation 49778.0	387504 pg/ml Standard Deviation 211630	327375 pg/ml Standard Deviation 208226	281413 pg/ml Standard Deviation 181027	191820 pg/ml Standard Deviation 123461	238304 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	326939 pg/ml Standard Deviation 184808	295378 pg/ml Standard Deviation 133164	62172.4 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 EOT: VEGF-A (n=5, 5, 2, 3, 4, 4, 5, 5, 17)	802.5 pg/ml Standard Deviation 880.22	991.3 pg/ml Standard Deviation 606.54	700.2 pg/ml Standard Deviation 406.16	231.6 pg/ml Standard Deviation 187.74	579.8 pg/ml Standard Deviation 205.68	511.0 pg/ml Standard Deviation 496.32	804.5 pg/ml Standard Deviation 577.55	1195.4 pg/ml Standard Deviation 1390.00	871.9 pg/ml Standard Deviation 1068.86
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 Baseline: PLGF (n=4, 3, 5, 3, 2, 7, 6, 5, 21)	13.4 pg/ml Standard Deviation 5.27	9.1 pg/ml Standard Deviation 5.69	9.3 pg/ml Standard Deviation 2.06	14.7 pg/ml Standard Deviation 4.30	6.4 pg/ml Standard Deviation 2.50	10.6 pg/ml Standard Deviation 1.98	13.4 pg/ml Standard Deviation 5.86	17.2 pg/ml Standard Deviation 9.83	22.3 pg/ml Standard Deviation 19.56
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D16H: PLGF (n=4, 3, 5, 3, 2, 7, 6, 5, 22)	8.9 pg/ml Standard Deviation 3.66	8.4 pg/ml Standard Deviation 1.56	6.1 pg/ml Standard Deviation 3.09	12.4 pg/ml Standard Deviation 2.94	6.4 pg/ml Standard Deviation 3.04	8.4 pg/ml Standard Deviation 1.91	8.7 pg/ml Standard Deviation 2.84	22.0 pg/ml Standard Deviation 25.07	15.0 pg/ml Standard Deviation 11.95
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D22: PLGF (n=4, 5, 6, 2, 3, 6, 6, 4, 18)	8.4 pg/ml Standard Deviation 3.28	11.3 pg/ml Standard Deviation 6.94	9.6 pg/ml Standard Deviation 3.98	9.5 pg/ml Standard Deviation 2.48	6.4 pg/ml Standard Deviation 0.85	6.6 pg/ml Standard Deviation 3.01	6.8 pg/ml Standard Deviation 2.19	13.6 pg/ml Standard Deviation 9.77	8.5 pg/ml Standard Deviation 1.89
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C2D1: PLGF (n=3, 2, 6, 1, 3, 4, 3, 2, 18)	8.3 pg/ml Standard Deviation 2.39	9.4 pg/ml Standard Deviation 4.81	7.6 pg/ml Standard Deviation 0.49	9.8 pg/ml Standard Deviation 3.55	11.0 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	7.3 pg/ml Standard Deviation 3.00	9.7 pg/ml Standard Deviation 5.09	16.5 pg/ml Standard Deviation 13.95	7.1 pg/ml Standard Deviation 1.91
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C3D1: PLGF (n=3, 2, 3, 1, 1, 4, 2, 1, 10)	6.9 pg/ml Standard Deviation 1.92	11.0 pg/ml Standard Deviation 3.87	15.2 pg/ml Standard Deviation 5.66	9.9 pg/ml Standard Deviation 4.37	7.5 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	11.9 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	7.1 pg/ml Standard Deviation 2.05	8.9 pg/ml Standard Deviation 3.54	7.0 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 EOT: PLGF (n=5, 4, 2, 2, 2, 3, 2, 4, 14)	7.8 pg/ml Standard Deviation 3.30	11.8 pg/ml Standard Deviation 3.15	8.3 pg/ml Standard Deviation 3.20	8.7 pg/ml Standard Deviation 0.64	8.6 pg/ml Standard Deviation 1.34	6.8 pg/ml Standard Deviation 3.39	9.1 pg/ml Standard Deviation 2.29	20.1 pg/ml Standard Deviation 12.45	19.9 pg/ml Standard Deviation 20.49
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 Baseline: TGFb1 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)	72635.0 pg/ml Standard Deviation 69063.0	192856 pg/ml Standard Deviation 167465	58530.3 pg/ml Standard Deviation 70338.7	188182 pg/ml Standard Deviation 199702	322573 pg/ml Standard Deviation 249585	174960 pg/ml Standard Deviation 171958	236277 pg/ml Standard Deviation 108993	190445 pg/ml Standard Deviation 113478	184332 pg/ml Standard Deviation 59292.8
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D16H: TGFb1 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)	66293.0 pg/ml Standard Deviation 47427.2	185701 pg/ml Standard Deviation 107677	203200 pg/ml Standard Deviation 158543	225230 pg/ml Standard Deviation 129870	269437 pg/ml Standard Deviation 225974	297119 pg/ml Standard Deviation 87426.7	265679 pg/ml Standard Deviation 89033.4	311792 pg/ml Standard Deviation 104827	282944 pg/ml Standard Deviation 196959
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D22: TGFb1 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)	65483.2 pg/ml Standard Deviation 35965.8	160128 pg/ml Standard Deviation 119814	328947 pg/ml Standard Deviation 271795	272123 pg/ml Standard Deviation 162239	307758 pg/ml Standard Deviation 206598	298611 pg/ml Standard Deviation 178683	234304 pg/ml Standard Deviation 146086	212425 pg/ml Standard Deviation 106195	340151 pg/ml Standard Deviation 232305
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C2D1: TGFb1 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)	65275.6 pg/ml Standard Deviation 48954.3	216478 pg/ml Standard Deviation 33849.2	162468 pg/ml Standard Deviation 63111.4	182580 pg/ml Standard Deviation 112201	213943 pg/ml Standard Deviation 64818.6	302708 pg/ml Standard Deviation 213685	258286 pg/ml Standard Deviation 88746.3	230125 pg/ml Standard Deviation 174311	156793 pg/ml Standard Deviation 108469
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 EOT: TGFb1 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)	95074.9 pg/ml Standard Deviation 92796.5	172056 pg/ml Standard Deviation 100831	279062 pg/ml Standard Deviation 214205	203631 pg/ml Standard Deviation 254400	292165 pg/ml Standard Deviation 163750	250882 pg/ml Standard Deviation 165972	336973 pg/ml Standard Deviation 225077	183926 pg/ml Standard Deviation 163333	486629 pg/ml Standard Deviation 381351
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 Baseline: VEGF-A (n=4, 5, 6, 3, 3, 8, 7, 6, 24)	613.5 pg/ml Standard Deviation 984.96	907.5 pg/ml Standard Deviation 479.21	222.3 pg/ml Standard Deviation 201.48	452.5 pg/ml Standard Deviation 328.65	522.2 pg/ml Standard Deviation 512.23	669.4 pg/ml Standard Deviation 608.96	437.7 pg/ml Standard Deviation 268.81	538.9 pg/ml Standard Deviation 421.35	634.6 pg/ml Standard Deviation 874.12
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D16H: VEGF-A (n=4, 3, 6, 3, 4, 8, 7, 6, 24)	671.1 pg/ml Standard Deviation 998.34	988.3 pg/ml Standard Deviation 646.26	476.4 pg/ml Standard Deviation 155.58	788.6 pg/ml Standard Deviation 578.29	592.6 pg/ml Standard Deviation 684.51	587.5 pg/ml Standard Deviation 437.86	542.3 pg/ml Standard Deviation 400.82	648.7 pg/ml Standard Deviation 482.00	671.6 pg/ml Standard Deviation 997.74
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C1D22: VEGF-A (n=4, 5, 6, 3, 4, 6, 7, 4, 20)	1078.9 pg/ml Standard Deviation 1095.02	564.3 pg/ml Standard Deviation 212.89	772.5 pg/ml Standard Deviation 466.51	786.5 pg/ml Standard Deviation 650.76	748.0 pg/ml Standard Deviation 527.71	479.2 pg/ml Standard Deviation 359.29	617.6 pg/ml Standard Deviation 481.63	656.6 pg/ml Standard Deviation 579.52	1432.7 pg/ml Standard Deviation 1566.42
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C2D1: VEGF-A (n=3, 2, 6, 3, 4, 5, 5, 2, 20)	1064.3 pg/ml Standard Deviation 2200.07	623.7 pg/ml Standard Deviation 330.44	321.7 pg/ml Standard Deviation 401.42	608.8 pg/ml Standard Deviation 789.07	671.0 pg/ml Standard Deviation 349.68	600.0 pg/ml Standard Deviation 529.40	653.6 pg/ml Standard Deviation 339.01	754.8 pg/ml Standard Deviation 683.82	1904.2 pg/ml Standard Deviation 2559.16
Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2 C3D1: VEGF-A (n=3, 2, 4, 3, 1, 4, 3, 1, 12)	641.8 pg/ml Standard Deviation 651.66	1106.9 pg/ml Standard Deviation 374.74	378.6 pg/ml Standard Deviation 427.52	633.0 pg/ml Standard Deviation 332.78	526.5 pg/ml Standard Deviation 324.46	710.1 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	621.1 pg/ml Standard Deviation 409.65	980.7 pg/ml Standard Deviation 656.43	76.4 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D16H: VEGF-d (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	2142.8 pg/ml Standard Deviation 1494.28	1521.1 pg/ml Standard Deviation 863.10	1554.8 pg/ml Standard Deviation 968.88	1862.7 pg/ml Standard Deviation 1422.39	1453.6 pg/ml Standard Deviation 469.17	1400.7 pg/ml Standard Deviation 634.61	2638.6 pg/ml Standard Deviation 3254.13	1487.3 pg/ml Standard Deviation 654.83	1031.1 pg/ml Standard Deviation 285.11
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D22: VEGF-d (n= 4, 5, 6, 3, 4, 6, 7, 5, 19)	2375.2 pg/ml Standard Deviation 1506.25	896.2 pg/ml Standard Deviation 257.64	1544.2 pg/ml Standard Deviation 952.69	1627.6 pg/ml Standard Deviation 1133.17	1376.2 pg/ml Standard Deviation 468.11	1916.3 pg/ml Standard Deviation 1499.55	2831.2 pg/ml Standard Deviation 3980.28	1634.0 pg/ml Standard Deviation 741.59	1191.6 pg/ml Standard Deviation 407.20
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C2D1: VEGF-d (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	1957.2 pg/ml Standard Deviation 963.83	1276.2 pg/ml Standard Deviation 830.02	1787.2 pg/ml Standard Deviation 1467.67	1873.7 pg/ml Standard Deviation 1363.68	1359.8 pg/ml Standard Deviation 590.91	2277.6 pg/ml Standard Deviation 2283.70	2557.3 pg/ml Standard Deviation 3427.60	1333.5 pg/ml Standard Deviation 404.55	1025.5 pg/ml Standard Deviation 132.44
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C3D1: VEGF-d (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	2094.4 pg/ml Standard Deviation 837.78	1259.9 pg/ml Standard Deviation 763.65	1826.2 pg/ml Standard Deviation 1660.36	1954.2 pg/ml Standard Deviation 1737.30	1300.9 pg/ml Standard Deviation 623.64	1584.0 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	3876.5 pg/ml Standard Deviation 5419.26	1100.3 pg/ml Standard Deviation 395.55	1470.1 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 EOT: VEGF-d (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	2011.1 pg/ml Standard Deviation 988.62	1259.0 pg/ml Standard Deviation 640.63	1463.6 pg/ml Standard Deviation 813.87	2218.0 pg/ml Standard Deviation 2141.83	1289.9 pg/ml Standard Deviation 633.94	2181.2 pg/ml Standard Deviation 1622.16	2079.0 pg/ml Standard Deviation 1987.67	1464.0 pg/ml Standard Deviation 959.39	1093.7 pg/ml Standard Deviation 308.36
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 Baseline: VEGFR1 (n= 5, 5, 6, 3, 4, 7, 7, 6, 23)	243.6 pg/ml Standard Deviation 128.59	1377.6 pg/ml Standard Deviation 2854.50	216.1 pg/ml Standard Deviation 302.01	118.1 pg/ml Standard Deviation 65.01	75.3 pg/ml Standard Deviation 20.82	262.3 pg/ml Standard Deviation 261.24	77.5 pg/ml Standard Deviation 39.81	219.5 pg/ml Standard Deviation 195.62	200.4 pg/ml Standard Deviation 119.61
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C3D1: VEGFR1 (n= 3, 2, 4, 3, 1, 4, 2, 1, 12)	236.1 pg/ml Standard Deviation 245.35	97.7 pg/ml Standard Deviation 45.58	2659.5 pg/ml Standard Deviation 3611.41	109.5 pg/ml Standard Deviation 34.95	244.4 pg/ml Standard Deviation 304.26	386.2 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	50.3 pg/ml Standard Deviation 26.44	388.4 pg/ml Standard Deviation 351.79	283.3 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D16H: VEGFR1 (n= 4, 3, 6, 3, 4, 8, 6, 6, 23)	251.7 pg/ml Standard Deviation 306.54	98.6 pg/ml Standard Deviation 45.70	230.0 pg/ml Standard Deviation 262.82	200.2 pg/ml Standard Deviation 241.23	258.4 pg/ml Standard Deviation 336.53	656.3 pg/ml Standard Deviation 1160.02	79.6 pg/ml Standard Deviation 62.56	362.6 pg/ml Standard Deviation 525.74	134.8 pg/ml Standard Deviation 83.44
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D22: VEGFR1 (n= 4, 5, 6, 3, 3, 5, 7, 4, 20)	187.6 pg/ml Standard Deviation 80.10	102.1 pg/ml Standard Deviation 40.47	325.0 pg/ml Standard Deviation 545.00	181.8 pg/ml Standard Deviation 207.89	79.2 pg/ml Standard Deviation 27.82	377.0 pg/ml Standard Deviation 372.66	77.8 pg/ml Standard Deviation 30.55	127.9 pg/ml Standard Deviation 91.93	149.3 pg/ml Standard Deviation 95.67
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C2D1: VEGFR1 (n= 3, 1, 6, 3, 4, 5, 5, 2, 20)	656.5 pg/ml Standard Deviation 2066.54	63.0 pg/ml Standard Deviation 24.69	1556.8 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	464.1 pg/ml Standard Deviation 611.85	81.9 pg/ml Standard Deviation 37.78	215.9 pg/ml Standard Deviation 236.35	56.4 pg/ml Standard Deviation 22.50	179.1 pg/ml Standard Deviation 153.00	164.5 pg/ml Standard Deviation 89.31
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 EOT: VEGFR1 (n= 5, 5, 2, 2, 4, 4, 4, 5, 17)	242.4 pg/ml Standard Deviation 140.35	125.2 pg/ml Standard Deviation 57.71	316.4 pg/ml Standard Deviation 561.02	412.9 pg/ml Standard Deviation 389.40	209.0 pg/ml Standard Deviation 148.00	173.1 pg/ml Standard Deviation 110.45	118.9 pg/ml Standard Deviation 22.12	365.3 pg/ml Standard Deviation 267.06	175.3 pg/ml Standard Deviation 138.87
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 Baseline: VEGF-C (n= 3, 1, 3, 2, 2, 4, 4, 4, 15)	123.1 pg/ml Standard Deviation 59.79	157.8 pg/ml Standard Deviation 47.72	129.4 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	80.8 pg/ml Standard Deviation 26.11	130.1 pg/ml Standard Deviation 74.10	200.7 pg/ml Standard Deviation 55.58	86.1 pg/ml Standard Deviation 25.17	85.5 pg/ml Standard Deviation 23.49	195.3 pg/ml Standard Deviation 164.87
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D16H: VEGF-C (n= 2, 2, 4, 2, 2, 5, 5, 4, 13)	144.2 pg/ml Standard Deviation 40.73	128.2 pg/ml Standard Deviation 82.17	41.8 pg/ml Standard Deviation 7.71	102.2 pg/ml Standard Deviation 27.40	146.0 pg/ml Standard Deviation 129.90	151.4 pg/ml Standard Deviation 67.03	116.9 pg/ml Standard Deviation 62.28	80.4 pg/ml Standard Deviation 24.55	120.2 pg/ml Standard Deviation 63.80
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C1D22: VEGF-C (n= 3, 5, 4, 2, 2, 4, 4, 4, 12)	154.1 pg/ml Standard Deviation 85.63	86.7 pg/ml Standard Deviation 58.88	85.7 pg/ml Standard Deviation 40.52	129.1 pg/ml Standard Deviation 129.05	82.3 pg/ml Standard Deviation 45.18	187.6 pg/ml Standard Deviation 8.84	103.8 pg/ml Standard Deviation 45.97	130.9 pg/ml Standard Deviation 78.92	193.8 pg/ml Standard Deviation 42.02
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C2D1: VEGF-C (n= 2, 1, 2, 1, 2, 4, 4, 1, 11)	201.4 pg/ml Standard Deviation 91.96	82.0 pg/ml Standard Deviation 56.92	102.8 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	73.0 pg/ml Standard Deviation 27.37	75.5 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	195.5 pg/ml Standard Deviation 22.56	78.1 pg/ml Standard Deviation 24.17	92.7 pg/ml Standard Deviation 60.15	209.0 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 C3D1: VEGF-C (n= 2, 1, 2, 0, 1, 3, 1, 0, 8)	190.5 pg/ml Standard Deviation 71.75	217.8 pg/ml Standard Deviation 175.08	139.8 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	100.2 pg/ml Standard Deviation 64.49	NA pg/ml Standard Deviation NA Data was not reported since no participant was evaluable for this arm group	72.5 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	93.6 pg/ml Standard Deviation 38.86	90.5 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	NA pg/ml Standard Deviation NA Data was not reported since no participant was evaluable for this arm group
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 EOT: VEGF-C (n= 5, 4, 0, 1, 2, 3, 4, 5, 10)	186.1 pg/ml Standard Deviation 91.79	140.0 pg/ml Standard Deviation 102.64	110.1 pg/ml Standard Deviation 55.86	NA pg/ml Standard Deviation NA Data was not reported since no participant was evaluable for this arm group	60.1 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	146.8 pg/ml Standard Deviation 108.75	131.8 pg/ml Standard Deviation 21.49	138.0 pg/ml Standard Deviation 112.15	114.9 pg/ml Standard Deviation 43.61
Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2 Baseline: VEGF-d (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	2127.8 pg/ml Standard Deviation 1620.79	1482.0 pg/ml Standard Deviation 661.38	2365.6 pg/ml Standard Deviation 2277.70	1694.0 pg/ml Standard Deviation 1200.02	1393.9 pg/ml Standard Deviation 371.40	2073.3 pg/ml Standard Deviation 1258.05	2421.0 pg/ml Standard Deviation 2415.95	1282.9 pg/ml Standard Deviation 308.22	1144.6 pg/ml Standard Deviation 214.88

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Population: Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.

Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.

Outcome measures

Outcome measures
Measure	PF-03446962 7 mg/kg: Part 2 n=24 Participants PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 0.5 mg/kg: Part 1 n=5 Participants PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 1 mg/kg: Part 1 n=5 Participants PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 2 mg/kg : Part 1 n=6 Participants PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 3 mg/kg: Part 1 n=3 Participants PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 4.5 mg/kg: Part 1 n=4 Participants PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 6.75 mg/kg: Part 1 n=8 Participants PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 10 mg/kg: Part 1 n=7 Participants PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.	PF-03446962 15 mg/kg: Part 1 n=6 Participants PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C1D22: VEGFR3 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)	439596 pg/ml Standard Deviation 117856	418199 pg/ml Standard Deviation 135460	413223 pg/ml Standard Deviation 111775	482016 pg/ml Standard Deviation 227736	278094 pg/ml Standard Deviation 29688.1	335397 pg/ml Standard Deviation 159853	405426 pg/ml Standard Deviation 135402	384832 pg/ml Standard Deviation 157842	367493 pg/ml Standard Deviation 104354
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C2D1: VEGFR3 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	436507 pg/ml Standard Deviation 130015	456367 pg/ml Standard Deviation 205119	283799 pg/ml Standard Deviation 30962.7	483165 pg/ml Standard Deviation 166891	299955 pg/ml Standard Deviation 42094.9	326823 pg/ml Standard Deviation 171815	403432 pg/ml Standard Deviation 164005	326291 pg/ml Standard Deviation 81142.0	330917 pg/ml Standard Deviation 3323.61
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C3D1: VEGFR3 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	401286 pg/ml Standard Deviation 120518	486756 pg/ml Standard Deviation 156161	335446 pg/ml Standard Deviation 688.51	380689 pg/ml Standard Deviation 189516	272982 pg/ml Standard Deviation 12015.1	563837 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	356012 pg/ml Standard Deviation 127436	301489 pg/ml Standard Deviation 85606.4	309162 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 EOT: VEGFR3 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	457457 pg/ml Standard Deviation 144474	456664 pg/ml Standard Deviation 83808.5	358829 pg/ml Standard Deviation 70878.1	396443 pg/ml Standard Deviation 324477	306684 pg/ml Standard Deviation 72478.1	319223 pg/ml Standard Deviation 117705	419244 pg/ml Standard Deviation 54326.1	446291 pg/ml Standard Deviation 293311	440490 pg/ml Standard Deviation 118906
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 Baseline: VEGFR2 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	6495.9 pg/ml Standard Deviation 2172.45	8414.2 pg/ml Standard Deviation 3145.86	8281.8 pg/ml Standard Deviation 4500.81	8834.8 pg/ml Standard Deviation 1749.43	10475.6 pg/ml Standard Deviation 862.91	9536.4 pg/ml Standard Deviation 2527.39	7526.1 pg/ml Standard Deviation 1910.18	7712.5 pg/ml Standard Deviation 2738.41	8934.9 pg/ml Standard Deviation 1266.00
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C1D16H: VEGFR2 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	6708.1 pg/ml Standard Deviation 2314.78	7989.8 pg/ml Standard Deviation 3208.34	7069.9 pg/ml Standard Deviation 5395.12	9884.4 pg/ml Standard Deviation 3258.50	10980.4 pg/ml Standard Deviation 1881.48	7707.1 pg/ml Standard Deviation 2003.97	7902.7 pg/ml Standard Deviation 2606.45	7500.6 pg/ml Standard Deviation 2409.88	8827.1 pg/ml Standard Deviation 1458.20
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C1D22: VEGFR2 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)	7147.6 pg/ml Standard Deviation 2735.63	8310.6 pg/ml Standard Deviation 4171.13	9672.8 pg/ml Standard Deviation 4841.31	9057.3 pg/ml Standard Deviation 1614.38	10248.0 pg/ml Standard Deviation 1886.86	8057.2 pg/ml Standard Deviation 1948.44	8912.0 pg/ml Standard Deviation 2327.17	9230.3 pg/ml Standard Deviation 4272.69	9572.0 pg/ml Standard Deviation 2736.01
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C2D1: VEGFR2 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)	7468.4 pg/ml Standard Deviation 2757.65	6699.4 pg/ml Standard Deviation 3398.50	9896.8 pg/ml Standard Deviation 1626.91	9191.5 pg/ml Standard Deviation 2061.89	9354.7 pg/ml Standard Deviation 2102.62	6621.2 pg/ml Standard Deviation 1637.27	8016.8 pg/ml Standard Deviation 1689.68	7727.3 pg/ml Standard Deviation 3137.81	8567.2 pg/ml Standard Deviation 222.95
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C3D1: VEGFR2 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)	7087.9 pg/ml Standard Deviation 2430.45	8780.4 pg/ml Standard Deviation 4855.85	9372.8 pg/ml Standard Deviation 1111.71	9736.1 pg/ml Standard Deviation 1396.40	9988.4 pg/ml Standard Deviation 1704.87	7180.0 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.	9289.2 pg/ml Standard Deviation 2003.70	9784.5 pg/ml Standard Deviation 2193.47	9632.8 pg/ml Standard Deviation NA Standard deviation was not reported since only 1 participant was evaluable for this arm group.
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 EOT: VEGFR2 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)	8151.0 pg/ml Standard Deviation 2254.12	9541.6 pg/ml Standard Deviation 3903.58	8297.5 pg/ml Standard Deviation 4291.01	7490.4 pg/ml Standard Deviation 5124.26	11521.7 pg/ml Standard Deviation 1822.45	8151.8 pg/ml Standard Deviation 2508.61	10018.0 pg/ml Standard Deviation 2860.16	7771.7 pg/ml Standard Deviation 3593.10	9357.8 pg/ml Standard Deviation 2845.47
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 Baseline: VEGFR3 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)	423268 pg/ml Standard Deviation 152555	421297 pg/ml Standard Deviation 89735.8	396991 pg/ml Standard Deviation 111696	340605 pg/ml Standard Deviation 106111	282449 pg/ml Standard Deviation 52144.0	336510 pg/ml Standard Deviation 183465	402326 pg/ml Standard Deviation 127490	377133 pg/ml Standard Deviation 109330	409280 pg/ml Standard Deviation 166548
Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2 C1D16H: VEGFR3 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)	427567 pg/ml Standard Deviation 133307	403555 pg/ml Standard Deviation 118261	417915 pg/ml Standard Deviation 101370	376867 pg/ml Standard Deviation 146099	282590 pg/ml Standard Deviation 58032.4	301990 pg/ml Standard Deviation 114920	371861 pg/ml Standard Deviation 130334	361958 pg/ml Standard Deviation 106007	375385 pg/ml Standard Deviation 89006.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)

Population: Data was reported in individual participant listings but not statistically summarized due to statistical constraints.

Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.

Outcome measures

Outcome data not reported

Adverse Events

PF-03446962

Serious events: 24 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-03446962 n=68 participants at risk All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \[mg/kg\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematemesis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Small intestinal obstruction	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Condition aggravated	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis acute	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood albumin decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Failure to thrive	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vaginal haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Embolism	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	PF-03446962 n=68 participants at risk All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \[mg/kg\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Ataxia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	10.3% 7/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	11.8% 8/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Gouty arthritis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukocytosis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	14.7% 10/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye discharge	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eyelid oedema	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain lower	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	8.8% 6/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ascites	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	11.8% 8/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	8.8% 6/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Melaena	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	26.5% 18/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Subileus	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	13.2% 9/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	25.0% 17/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	10.3% 7/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	27.9% 19/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	17.6% 12/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pelvic mass	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	17.6% 12/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Gallbladder disorder	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hypertransaminasaemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Portal vein thrombosis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes simplex	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinovirus infection	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Skin infection	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	8.8% 6/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Periorbital haematoma	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Subcutaneous haematoma	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Ammonia increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Amylase increased	11.8% 8/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	14.7% 10/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Breath sounds abnormal	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram QT prolonged	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Heart rate increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Laboratory test abnormal	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	11.8% 8/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Liver function test abnormal	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	11.8% 8/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	17.6% 12/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	10.3% 7/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary incontinence	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Scrotal oedema	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Testicular oedema	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	20.6% 14/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.2% 9/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.8% 6/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Swelling face	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Telangiectasia	8.8% 6/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	7.4% 5/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Intra-abdominal haematoma	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Vasodilatation	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphopenia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Photopsia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vitreous floaters	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Influenza like illness	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Cytokine release syndrome	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Multiple allergies	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fungal oesophagitis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood albumin decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood calcium decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood sodium decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood uric acid increased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Creatinine renal clearance decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight increased	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypernatraemia	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 4/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Groin pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle twitching	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Encephalopathy	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Pelvic pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.4% 3/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	2.9% 2/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Night sweats	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash papular	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Jugular vein thrombosis	1.5% 1/68 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

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