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
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Reported measurements
ANEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
16
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
6
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
38
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
16
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
9
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
7
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
HEMOGLOBIN INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
60
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
35
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
LYMPHOCYTE COUNT DECREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
9
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
27
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
20
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
21
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
11
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
5
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
LYMPHOCYTE COUNT INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
14
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
63
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
37
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
NEUTROPHIL COUNT DECREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
61
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
35
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
PLATELET COUNT DECREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
12
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
56
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
33
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
12
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
5
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
WHITE BLOOD CELL DECREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
10
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
62
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
34
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
ALANINE AMINOTRANSFERASE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
14
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
45
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
31
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
19
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
ALKALINE PHOSPHATASE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
6
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
36
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
21
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
22
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
11
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
4
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
ASPARTATE AMINOTRANSFERASE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
67
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
11
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
44
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
23
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
17
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
13
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
BLOOD BILIRUBIN INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
58
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
34
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
6
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
CPK INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
3
Part 2: PF-06801591 300 mg (SC) for UC
0
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
CREATININE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
58
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
6
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
30
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
5
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
GGT INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
4
Part 2: PF-06801591 300 mg (SC) for UC
2
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPERCALCEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
51
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
31
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
5
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
HYPERGLYCEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
14
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
24
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
12
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
31
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
21
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
10
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
4
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPERKALEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
48
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
27
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
6
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
11
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPERMAGNESEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
55
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
35
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
6
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPERNATREMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
51
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
35
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
HYPOALBUMINEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
10
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
40
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
23
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
18
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
11
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
10
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
4
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
HYPOCALCEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
49
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
30
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
12
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
7
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
HYPOGLYCEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
8
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
60
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
32
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
6
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPOKALEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
10
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
61
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
33
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPOMAGNESEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
42
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
29
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
14
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
8
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
HYPONATREMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
8
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
45
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
25
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
19
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
10
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
HYPOPHOSPHATEMIA
Analysis denominator · Participants
Group
Source 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 NSCLC
67
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
56
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
27
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
7
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
4
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
LIPASE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
37
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
50
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
23
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
11
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
7
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
SERUM AMYLASE INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
7
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
13
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
45
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
23
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
16
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
10
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
2
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
PROTEINURIA
Analysis denominator · Participants
Group
Source 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 NSCLC
66
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
9
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
46
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
15
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
6
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
15
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
17
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
5
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
38
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
11
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
44
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
19
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
19
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
15
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
3
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
INR INCREASED
Analysis denominator · Participants
Group
Source 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 NSCLC
68
Part 2: PF-06801591 300 mg (SC) for UC
36
Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
5
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
6
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
4
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
12
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
39
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
31
Not reported
Not reported
Not reported
Not reported
Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
2
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
3
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
25
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
4
Not reported
Not reported
Not reported
Not reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
1
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
1
Not reported
Not reported
Not reported
Not reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 1 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 3 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 10 mg/kg (IV)
0
Not reported
Not reported
Not reported
Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
0
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: PF-06801591 300 mg (SC) for UC
0
Not reported
Not reported
Not reported
Not reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 1 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 3 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 10 mg/kg (IV)
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for NSCLC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Part 2: PF-06801591 300 mg (SC) for UC
NA
Not reported
Not reported
Not reported
CTCAE grade not defined.
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
16
group Id
OG006
value
6
title
Grade 0
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
5
group Id
OG005
value
38
group Id
OG006
value
16
title
Grade 1
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
1
group Id
OG004
value
8
group Id
OG005
value
13
group Id
OG006
value
9
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
7
title
Grade 3
measurements
comment
CTCAE grade not defined.
group Id
OG000
value
NA
comment
CTCAE grade not defined.
group Id
OG001
value
NA
comment
CTCAE grade not defined.
group Id
OG002
value
NA
comment
CTCAE grade not defined.
group Id
OG003
value
NA
comment
CTCAE grade not defined.
group Id
OG004
value
NA
comment
CTCAE grade not defined.
group Id
OG005
value
NA
comment
CTCAE grade not defined.
group Id
OG006
value
NA
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
ANEMIA
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
60
group Id
OG006
value
35
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
7
group Id
OG006
value
3
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 3
measurements
comment
CTCAE grade not defined.
group Id
OG000
value
NA
comment
CTCAE grade not defined.
group Id
OG001
value
NA
comment
CTCAE grade not defined.
group Id
OG002
value
NA
comment
CTCAE grade not defined.
group Id
OG003
value
NA
comment
CTCAE grade not defined.
group Id
OG004
value
NA
comment
CTCAE grade not defined.
group Id
OG005
value
NA
comment
CTCAE grade not defined.
group Id
OG006
value
NA
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
HEMOGLOBIN INCREASED
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
9
group Id
OG005
value
27
group Id
OG006
value
20
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
21
group Id
OG006
value
11
title
Grade 1
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
4
group Id
OG004
value
1
group Id
OG005
value
15
group Id
OG006
value
5
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
3
group Id
OG005
value
5
group Id
OG006
value
2
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
LYMPHOCYTE COUNT DECREASED
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
14
group Id
OG005
value
63
group Id
OG006
value
37
title
Grade 0
measurements
comment
CTCAE grade not defined.
group Id
OG000
value
NA
comment
CTCAE grade not defined.
group Id
OG001
value
NA
comment
CTCAE grade not defined.
group Id
OG002
value
NA
comment
CTCAE grade not defined.
group Id
OG003
value
NA
comment
CTCAE grade not defined.
group Id
OG004
value
NA
comment
CTCAE grade not defined.
group Id
OG005
value
NA
comment
CTCAE grade not defined.
group Id
OG006
value
NA
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
5
group Id
OG006
value
1
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 3
measurements
comment
CTCAE grade not defined.
group Id
OG000
value
NA
comment
CTCAE grade not defined.
group Id
OG001
value
NA
comment
CTCAE grade not defined.
group Id
OG002
value
NA
comment
CTCAE grade not defined.
group Id
OG003
value
NA
comment
CTCAE grade not defined.
group Id
OG004
value
NA
comment
CTCAE grade not defined.
group Id
OG005
value
NA
comment
CTCAE grade not defined.
group Id
OG006
value
NA
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
LYMPHOCYTE COUNT INCREASED
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
group Id
OG002
value
7
group Id
OG003
value
5
group Id
OG004
value
13
group Id
OG005
value
61
group Id
OG006
value
35
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
4
group Id
OG006
value
0
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
3
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
NEUTROPHIL COUNT DECREASED
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
group Id
OG002
value
7
group Id
OG003
value
6
group Id
OG004
value
12
group Id
OG005
value
56
group Id
OG006
value
33
title
Grade 0
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
3
group Id
OG005
value
12
group Id
OG006
value
5
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
PLATELET COUNT DECREASED
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
10
group Id
OG005
value
62
group Id
OG006
value
34
title
Grade 0
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
3
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
1
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
WHITE BLOOD CELL DECREASED
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
4
group Id
OG004
value
14
group Id
OG005
value
45
group Id
OG006
value
31
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
19
group Id
OG006
value
3
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
3
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
3
group Id
OG006
value
1
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
ALANINE AMINOTRANSFERASE INCREASED
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
4
group Id
OG004
value
6
group Id
OG005
value
36
group Id
OG006
value
21
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
7
group Id
OG005
value
22
group Id
OG006
value
11
title
Grade 1
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
7
group Id
OG006
value
4
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
3
group Id
OG006
value
2
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
ALKALINE PHOSPHATASE INCREASED
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
7
group Id
OG003
value
5
group Id
OG004
value
11
group Id
OG005
value
44
group Id
OG006
value
23
title
Grade 0
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
4
group Id
OG005
value
17
group Id
OG006
value
13
title
Grade 1
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
5
group Id
OG006
value
1
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
1
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
67
group Id
OG006
value
38
units
Participants
title
ASPARTATE AMINOTRANSFERASE INCREASED
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
group Id
OG002
value
7
group Id
OG003
value
6
group Id
OG004
value
13
group Id
OG005
value
58
group Id
OG006
value
34
title
Grade 0
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
6
group Id
OG006
value
3
title
Grade 1
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
3
group Id
OG006
value
1
title
Grade 2
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Grade 3
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
group Id
OG006
value
38
units
Participants
title
BLOOD BILIRUBIN INCREASED
categories
measurements
group Id
OG005
value
3
title
Grade 0
measurements
group Id
OG005
value
0
title
Grade 1
measurements
group Id
OG005
value
0
title
Grade 2
measurements
group Id
OG005
value
0
title
Grade 3
measurements
group Id
OG005
value
0
title
Grade 4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
3
group Id
OG006
value
0
units
Participants
title
CPK INCREASED
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
15
group Id
OG005
value
68
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
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])
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)
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)
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)
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])
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
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