NCT01721772 · OUTCOME

Progression-free Survival (PFS) Rate

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12

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

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization to the specified timepoints, up to 84 months

What was measured

The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine

Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

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
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	210
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	208

Reported measurements

At 6 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	48.2	Not reported	41.0	55.0	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	20.0	Not reported	14.6	26.1	Not reported

At 12 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	43.3	Not reported	36.3	50.2	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	7.4	Not reported	3.9	12.4	Not reported

At 18 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	40.5	Not reported	33.5	47.4	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	5.2	Not reported	2.2	10.2	Not reported

At 24 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	35.8	Not reported	29.0	42.6	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	5.2	Not reported	2.2	10.2	Not reported

At 36 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	32.8	Not reported	26.1	39.6	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	3.9	Not reported	1.3	8.9	Not reported

At 48 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	29.7	Not reported	23.2	36.5	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	3.9	Not reported	1.3	8.9	Not reported

At 60 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	28.4	Not reported	22.0	35.2	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	3.9	Not reported	1.3	8.9	Not reported

At 72 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	27.8	Not reported	21.4	34.5	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	3.9	Not reported	1.3	8.9	Not reported

At 84 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	25.9	Not reported	19.5	32.7	Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	3.9	Not reported	1.3	8.9	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
41.0
upper Limit
55.0
value
48.2
group Id
OG001
lower Limit
14.6
upper Limit
26.1
value
20.0
title
At 6 months
categories
measurements
group Id
OG000
lower Limit
36.3
upper Limit
50.2
value
43.3
group Id
OG001
lower Limit
3.9
upper Limit
12.4
value
7.4
title
At 12 months
categories
measurements
group Id
OG000
lower Limit
33.5
upper Limit
47.4
value
40.5
group Id
OG001
lower Limit
2.2
upper Limit
10.2
value
5.2
title
At 18 months
categories
measurements
group Id
OG000
lower Limit
29.0
upper Limit
42.6
value
35.8
group Id
OG001
lower Limit
2.2
upper Limit
10.2
value
5.2
title
At 24 months
categories
measurements
group Id
OG000
lower Limit
26.1
upper Limit
39.6
value
32.8
group Id
OG001
lower Limit
1.3
upper Limit
8.9
value
3.9
title
At 36 months
categories
measurements
group Id
OG000
lower Limit
23.2
upper Limit
36.5
value
29.7
group Id
OG001
lower Limit
1.3
upper Limit
8.9
value
3.9
title
At 48 months
categories
measurements
group Id
OG000
lower Limit
22.0
upper Limit
35.2
value
28.4
group Id
OG001
lower Limit
1.3
upper Limit
8.9
value
3.9
title
At 60 months
categories
measurements
group Id
OG000
lower Limit
21.4
upper Limit
34.5
value
27.8
group Id
OG001
lower Limit
1.3
upper Limit
8.9
value
3.9
title
At 72 months
categories
measurements
group Id
OG000
lower Limit
19.5
upper Limit
32.7
value
25.9
group Id
OG001
lower Limit
1.3
upper Limit
8.9
value
3.9
title
At 84 months

denoms

counts
group Id
OG000
value
210
group Id
OG001
value
208
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id
OG000
title
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
description
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id
OG001
title
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

param Type

NUMBER

population Description

All randomized participants

reporting Status

POSTED

time Frame

From randomization to the specified timepoints, up to 84 months

title

Progression-free Survival (PFS) Rate

type

SECONDARY

unit Of Measure

Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice