NCT02573259 · OUTCOME

Probability of Survival at 6 Months, 1 Year, and 2 Years - 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: NUMBER
Unit: Probability
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)

What was measured

Probability of survival was calculated from the product-limit method.

Analysis population: Analysis population included all the randomized participants who received PF-06801591 and had at least 1 post-dose concentration measurement above the lower limit of quantification (LLQ).

Groups in this outcome

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 2: PF-06801591 300 mg (SC) for NSCLC	68
Part 2: PF-06801591 300 mg (SC) for UC	39

Reported measurements

6 Months

Values in Probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC	0.773	Not reported	0.647	0.859	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	0.711	Not reported	0.527	0.833	Not reported

1 Year

Values in Probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC	0.547	Not reported	0.407	0.667	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	0.471	Not reported	0.290	0.633	Not reported

2 Years

Values in Probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part 2: PF-06801591 300 mg (SC) for NSCLC	0.403	Not reported	0.265	0.537	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	0.286	Not reported	0.127	0.467	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.647
upper Limit
0.859
value
0.773
group Id
OG001
lower Limit
0.527
upper Limit
0.833
value
0.711
title
6 Months
categories
measurements
group Id
OG000
lower Limit
0.407
upper Limit
0.667
value
0.547
group Id
OG001
lower Limit
0.290
upper Limit
0.633
value
0.471
title
1 Year
categories
measurements
group Id
OG000
lower Limit
0.265
upper Limit
0.537
value
0.403
group Id
OG001
lower Limit
0.127
upper Limit
0.467
value
0.286
title
2 Years

denoms

counts
group Id
OG000
value
68
group Id
OG001
value
39
units
Participants

description

Probability of survival was calculated from the product-limit method.

dispersion Type

95% Confidence Interval

groups

description
Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
id
OG000
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
OG001
title
Part 2: PF-06801591 300 mg (SC) for UC

param Type

NUMBER

population Description

Analysis population included all the randomized participants who received PF-06801591 and had at least 1 post-dose concentration measurement above the lower limit of quantification (LLQ).

reporting Status

POSTED

time Frame

Baseline up to end of treatment in Part 2 (maximum of 851 days)

title

Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2

type

SECONDARY

unit Of Measure

Probability

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

Preserved source evidence · Not medical advice