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NCT02573259 · OUTCOME

Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)

What was measured

Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

Analysis population: Analysis population included all enrolled participants who received at least 1 dose of study medication.

Groups in this outcome

Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Reported measurements

ANEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC16Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC6Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC38Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC16Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC9Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC7Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
HEMOGLOBIN INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC60Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC35Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
LYMPHOCYTE COUNT DECREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])9Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC27Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC20Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC21Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC11Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC5Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
LYMPHOCYTE COUNT INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])14Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC63Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC37Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
NEUTROPHIL COUNT DECREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC61Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC35Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
PLATELET COUNT DECREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])12Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC56Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC33Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC12Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC5Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
WHITE BLOOD CELL DECREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])10Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC62Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC34Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
ALANINE AMINOTRANSFERASE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])14Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC45Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC31Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC19Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
ALKALINE PHOSPHATASE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])6Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC36Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC21Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC22Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC11Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC4Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
ASPARTATE AMINOTRANSFERASE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC67
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])11Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC44Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC23Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC17Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC13Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported
BLOOD BILIRUBIN INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC58Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC34Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC6Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
CPK INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0
Part 1: PF-06801591 1 mg/kg (IV)0
Part 1: PF-06801591 3 mg/kg (IV)0
Part 1: PF-06801591 10 mg/kg (IV)0
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0
Part 2: PF-06801591 300 mg (SC) for NSCLC3
Part 2: PF-06801591 300 mg (SC) for UC0

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
CREATININE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC58Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC6Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC30Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC5Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
GGT INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1
Part 1: PF-06801591 1 mg/kg (IV)0
Part 1: PF-06801591 3 mg/kg (IV)0
Part 1: PF-06801591 10 mg/kg (IV)0
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0
Part 2: PF-06801591 300 mg (SC) for NSCLC4
Part 2: PF-06801591 300 mg (SC) for UC2

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPERCALCEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC51Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC31Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC5Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported
HYPERGLYCEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])14Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC24Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC12Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC31Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC21Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC10Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC4Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPERKALEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC48Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC27Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC6Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC11Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPERMAGNESEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC55Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC35Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC6Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPERNATREMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC51Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC35Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported
HYPOALBUMINEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])10Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC40Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC23Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC18Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC11Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC10Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC4Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
HYPOCALCEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC49Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC30Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC12Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC7Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported
HYPOGLYCEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)8Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC60Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC32Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC6Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPOKALEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])10Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC61Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC33Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPOMAGNESEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC42Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC29Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC14Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC8Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
HYPONATREMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])8Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC45Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC25Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC19Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC10Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported
HYPOPHOSPHATEMIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC67
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC56Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC27Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC7Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC4Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
LIPASE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC37

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC50Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC23Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC11Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC7Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC2Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported
SERUM AMYLASE INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)7Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC45Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC23Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC16Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC10Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC2Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
PROTEINURIA

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)6
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC66
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])9Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC46Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC15Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])6Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC15Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC17Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC5Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC38

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])11Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC44Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC19Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC19Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC15Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC4Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
INR INCREASED

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC68
Part 2: PF-06801591 300 mg (SC) for UC36

Grade 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)5Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)6Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)4Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])12Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC39Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC31Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)3Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC25Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC4Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC1Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)0Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])0Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3Not reportedNot reportedNot reportedNot reported
Part 2: PF-06801591 300 mg (SC) for UC0Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UCNANot reportedNot reportedNot reportedCTCAE grade not defined.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        16
      7. group Id
        OG006
        value
        6
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        38
      7. group Id
        OG006
        value
        16
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        9
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        7
      title
      Grade 3
    5. measurements
      1. comment
        CTCAE grade not defined.
        group Id
        OG000
        value
        NA
      2. comment
        CTCAE grade not defined.
        group Id
        OG001
        value
        NA
      3. comment
        CTCAE grade not defined.
        group Id
        OG002
        value
        NA
      4. comment
        CTCAE grade not defined.
        group Id
        OG003
        value
        NA
      5. comment
        CTCAE grade not defined.
        group Id
        OG004
        value
        NA
      6. comment
        CTCAE grade not defined.
        group Id
        OG005
        value
        NA
      7. comment
        CTCAE grade not defined.
        group Id
        OG006
        value
        NA
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    ANEMIA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        60
      7. group Id
        OG006
        value
        35
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        7
      7. group Id
        OG006
        value
        3
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. comment
        CTCAE grade not defined.
        group Id
        OG000
        value
        NA
      2. comment
        CTCAE grade not defined.
        group Id
        OG001
        value
        NA
      3. comment
        CTCAE grade not defined.
        group Id
        OG002
        value
        NA
      4. comment
        CTCAE grade not defined.
        group Id
        OG003
        value
        NA
      5. comment
        CTCAE grade not defined.
        group Id
        OG004
        value
        NA
      6. comment
        CTCAE grade not defined.
        group Id
        OG005
        value
        NA
      7. comment
        CTCAE grade not defined.
        group Id
        OG006
        value
        NA
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    HEMOGLOBIN INCREASED
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        27
      7. group Id
        OG006
        value
        20
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        21
      7. group Id
        OG006
        value
        11
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        5
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    LYMPHOCYTE COUNT DECREASED
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        63
      7. group Id
        OG006
        value
        37
      title
      Grade 0
    2. measurements
      1. comment
        CTCAE grade not defined.
        group Id
        OG000
        value
        NA
      2. comment
        CTCAE grade not defined.
        group Id
        OG001
        value
        NA
      3. comment
        CTCAE grade not defined.
        group Id
        OG002
        value
        NA
      4. comment
        CTCAE grade not defined.
        group Id
        OG003
        value
        NA
      5. comment
        CTCAE grade not defined.
        group Id
        OG004
        value
        NA
      6. comment
        CTCAE grade not defined.
        group Id
        OG005
        value
        NA
      7. comment
        CTCAE grade not defined.
        group Id
        OG006
        value
        NA
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        1
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. comment
        CTCAE grade not defined.
        group Id
        OG000
        value
        NA
      2. comment
        CTCAE grade not defined.
        group Id
        OG001
        value
        NA
      3. comment
        CTCAE grade not defined.
        group Id
        OG002
        value
        NA
      4. comment
        CTCAE grade not defined.
        group Id
        OG003
        value
        NA
      5. comment
        CTCAE grade not defined.
        group Id
        OG004
        value
        NA
      6. comment
        CTCAE grade not defined.
        group Id
        OG005
        value
        NA
      7. comment
        CTCAE grade not defined.
        group Id
        OG006
        value
        NA
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    LYMPHOCYTE COUNT INCREASED
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        61
      7. group Id
        OG006
        value
        35
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        0
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    NEUTROPHIL COUNT DECREASED
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        56
      7. group Id
        OG006
        value
        33
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        5
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    PLATELET COUNT DECREASED
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        62
      7. group Id
        OG006
        value
        34
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        3
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    WHITE BLOOD CELL DECREASED
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        45
      7. group Id
        OG006
        value
        31
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        19
      7. group Id
        OG006
        value
        3
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        3
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        1
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    ALANINE AMINOTRANSFERASE INCREASED
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        36
      7. group Id
        OG006
        value
        21
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        22
      7. group Id
        OG006
        value
        11
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        7
      7. group Id
        OG006
        value
        4
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        2
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    ALKALINE PHOSPHATASE INCREASED
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        44
      7. group Id
        OG006
        value
        23
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        17
      7. group Id
        OG006
        value
        13
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        1
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        67
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    ASPARTATE AMINOTRANSFERASE INCREASED
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        58
      7. group Id
        OG006
        value
        34
      title
      Grade 0
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        3
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        1
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        68
      7. group Id
        OG006
        value
        38
      units
      Participants
    title
    BLOOD BILIRUBIN INCREASED
  12. categories
    1. measurements
      1. group Id
        OG005
        value
        3
      title
      Grade 0
    2. measurements
      1. group Id
        OG005
        value
        0
      title
      Grade 1
    3. measurements
      1. group Id
        OG005
        value
        0
      title
      Grade 2
    4. measurements
      1. group Id
        OG005
        value
        0
      title
      Grade 3
    5. measurements
      1. group Id
        OG005
        value
        0
      title
      Grade 4
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        0
      units
      Participants
    title
    CPK INCREASED
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      15
    6. group Id
      OG005
      value
      68
    7. group Id
      OG006
      value
      38
    units
    Participants
description
Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
groups
  1. description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    OG000
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    OG001
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    OG002
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    OG003
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    OG004
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  6. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG005
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  7. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG006
    title
    Part 2: PF-06801591 300 mg (SC) for UC
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis population included all enrolled participants who received at least 1 dose of study medication.
reporting Status
POSTED
time Frame
Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
title
Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice