NCT02573259 · OUTCOME

Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - 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

AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. 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)	8
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

Participants with AEs

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	62	Not reported	Not reported	Not reported	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	36	Not reported	Not reported	Not reported	Not reported

Participants with SAEs

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)	3	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])	3	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	13	Not reported	Not reported	Not reported	Not reported

Participants with maximum Grade 3 or 4 AEs

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)	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])	4	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	13	Not reported	Not reported	Not reported	Not reported

Participants with maximum Grade 5 AEs

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])	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	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

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
62
group Id
OG006
value
36
title
Participants with AEs
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
18
group Id
OG006
value
13
title
Participants with SAEs
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
18
group Id
OG006
value
13
title
Participants with maximum Grade 3 or 4 AEs
categories
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
0
group Id
OG005
value
8
group Id
OG006
value
5
title
Participants with maximum Grade 5 AEs

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
8
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

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 All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice