NCT01667419 · OUTCOME

Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)

What was measured

DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.

Analysis population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.

Groups in this outcome

Cohort 1 Vemurafenib

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 1 Placebo

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Vemurafenib

Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Placebo

Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

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
Cohort 1 Vemurafenib	157
Cohort 1 Placebo	157
Cohort 2 Vemurafenib	93
Cohort 2 Placebo	91

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort 1 Vemurafenib	NA	Not reported	NA	NA	Not estimable due to low number of events.
Cohort 1 Placebo	NA	Not reported	36.9	NA	Not estimable due to low number of events.
Cohort 2 Vemurafenib	37.2	Not reported	22.1	NA	Not estimable due to low number of events.
Cohort 2 Placebo	30.7	Not reported	24.5	NA	Not estimable due to low number of events.

Source statistical analyses

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

ci Lower Limit
0.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.90
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0133
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.44
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.6815
param Type
Hazard Ratio (HR)
param Value
0.91
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.37
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.90
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0133
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.44
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.6815
param Type
Hazard Ratio (HR)
param Value
0.91
statistical Method
Log Rank

classes

categories
measurements
comment
Not estimable due to low number of events.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Not estimable due to low number of events.
group Id
OG001
lower Limit
36.9
upper Limit
NA
value
NA
comment
Not estimable due to low number of events.
group Id
OG002
lower Limit
22.1
upper Limit
NA
value
37.2
comment
Not estimable due to low number of events.
group Id
OG003
lower Limit
24.5
upper Limit
NA
value
30.7

denoms

counts
group Id
OG000
value
157
group Id
OG001
value
157
group Id
OG002
value
93
group Id
OG003
value
91
units
Participants

description

DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.

dispersion Type

95% Confidence Interval

groups

description
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
id
OG000
title
Cohort 1 Vemurafenib
description
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
id
OG001
title
Cohort 1 Placebo
description
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
id
OG002
title
Cohort 2 Vemurafenib
description
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
id
OG003
title
Cohort 2 Placebo

param Type

MEDIAN

population Description

The ITT population included all participants enrolled in the study, whether or not they had received study medication.

reporting Status

POSTED

time Frame

From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)

title

Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice