NCT01006980 · OUTCOME

Overall Survival

A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) · Source last updated 2016-09-28

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).

What was measured

An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.

Analysis population: The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.

Groups in this outcome

Vemurafenib

Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).

Dacarbazine

Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).

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
Vemurafenib	336
Dacarbazine	336

Reported measurements

Participants with events

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vemurafenib	43	Not reported	Not reported	Not reported	Not reported
Dacarbazine	75	Not reported	Not reported	Not reported	Not reported

Participants without events

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vemurafenib	293	Not reported	Not reported	Not reported	Not reported
Dacarbazine	261	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.26
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.55
estimate Comment
The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.
group Description
The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.37
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.26
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.55
estimate Comment
The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.
group Description
The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.37
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
43
group Id
OG001
value
75
title
Participants with events
categories
measurements
group Id
OG000
value
293
group Id
OG001
value
261
title
Participants without events

denoms

counts
group Id
OG000
value
336
group Id
OG001
value
336
units
Participants

description

An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.

groups

description
Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
id
OG000
title
Vemurafenib
description
Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
id
OG001
title
Dacarbazine

param Type

NUMBER

population Description

The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.

reporting Status

POSTED

time Frame

From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).

title

Overall Survival

type

PRIMARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice