NCT00636168 · OUTCOME

Rate of Overall Survival (OS)

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma · Source last updated 2019-12-17

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 date of randomization to date of death, assessed up to 9 years

What was measured

OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.Yearly survival rates, e.g. at 3 years, defined as the probability that a participant was alive at 3 years following randomization, were estimated via the Kaplan-Meier method

Analysis population: Intent to Treat Population: All randomized participants,analyzed in the arm to which they were allocated by randomization

Groups in this outcome

Ipilimumab 10mg/kg

Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).

Placebo

Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).

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
Ipilimumab 10mg/kg	475
Placebo	476

Reported measurements

OS Rate at 1 year

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	93.53	Not reported	90.88	95.43	Not reported
Placebo	87.72	Not reported	84.40	90.37	Not reported

OS Rate at 2 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	82.55	Not reported	78.76	85.73	Not reported
Placebo	75.27	Not reported	71.10	78.92	Not reported

OS Rate at 3 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	74.20	Not reported	69.90	77.98	Not reported
Placebo	65.43	Not reported	60.91	69.56	Not reported

OS Rate at 4 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	67.79	Not reported	63.24	71.90	Not reported
Placebo	60.34	Not reported	55.72	64.64	Not reported

OS Rate at 5 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	65.42	Not reported	60.80	69.64	Not reported
Placebo	54.43	Not reported	49.71	58.89	Not reported

OS Rate at 7 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ipilimumab 10mg/kg	60.0	Not reported	55.0	64.7	Not reported
Placebo	51.3	Not reported	46.5	55.9	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
90.88
upper Limit
95.43
value
93.53
group Id
OG001
lower Limit
84.40
upper Limit
90.37
value
87.72
title
OS Rate at 1 year
categories
measurements
group Id
OG000
lower Limit
78.76
upper Limit
85.73
value
82.55
group Id
OG001
lower Limit
71.10
upper Limit
78.92
value
75.27
title
OS Rate at 2 years
categories
measurements
group Id
OG000
lower Limit
69.90
upper Limit
77.98
value
74.20
group Id
OG001
lower Limit
60.91
upper Limit
69.56
value
65.43
title
OS Rate at 3 years
categories
measurements
group Id
OG000
lower Limit
63.24
upper Limit
71.90
value
67.79
group Id
OG001
lower Limit
55.72
upper Limit
64.64
value
60.34
title
OS Rate at 4 years
categories
measurements
group Id
OG000
lower Limit
60.80
upper Limit
69.64
value
65.42
group Id
OG001
lower Limit
49.71
upper Limit
58.89
value
54.43
title
OS Rate at 5 years
categories
measurements
group Id
OG000
lower Limit
55.0
upper Limit
64.7
value
60.0
group Id
OG001
lower Limit
46.5
upper Limit
55.9
value
51.3
title
OS Rate at 7 years

denoms

counts
group Id
OG000
value
475
group Id
OG001
value
476
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
id
OG000
title
Ipilimumab 10mg/kg
description
Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
id
OG001
title
Placebo

param Type

NUMBER

population Description

Intent to Treat Population: All randomized participants,analyzed in the arm to which they were allocated by randomization

reporting Status

POSTED

time Frame

From date of randomization to date of death, assessed up to 9 years

title

Rate of Overall Survival (OS)

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice