NCT02573259 · OUTCOME

Number of Participants With Treatment-Related 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

Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. 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)	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	42	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

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])	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

Participants with maximum of 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])	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)	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	9	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

Participants with maximum of Grade 5 AEs

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 1 mg/kg (IV)	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 3 mg/kg (IV)	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 10 mg/kg (IV)	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	Not reported	Not reported	Not reported	Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC	Not reported	Not reported	Not reported	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
group Id
OG002
value
7
group Id
OG003
value
6
group Id
OG004
value
13
group Id
OG005
value
42
group Id
OG006
value
17
title
Participants with AEs
categories
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
Participants with SAEs
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
9
group Id
OG006
value
5
title
Participants with maximum of Grade 3 or 4 AEs
categories
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
Participants with maximum of 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 Treatment-Related 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