NCT02610140 · OUTCOME

Overall Survival (OS) - Addendum

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-11-04

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

Measure: MEAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause

What was measured

Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019.

Analysis population: The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.

Groups in this outcome

Anetumab Ravtansine

Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour

Vinorelbine

Active comparator: 30 mg/m\^2 once weekly

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
Anetumab Ravtansine	166
Vinorelbine	82

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Anetumab Ravtansine	9.5	Not reported	8.3	12.3	Not reported
Vinorelbine	11.6	Not reported	8.6	13.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
39.3
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Mean Difference (Final Values)
param Value
9.5
ci Lower Limit
0.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
35.9
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Mean Difference (Final Values)
param Value
11.6

Complete source fields

analyses

ci Lower Limit
0.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
39.3
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Mean Difference (Final Values)
param Value
9.5
ci Lower Limit
0.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
35.9
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Mean Difference (Final Values)
param Value
11.6

classes

categories
measurements
group Id
OG000
lower Limit
8.3
upper Limit
12.3
value
9.5
group Id
OG001
lower Limit
8.6
upper Limit
13.1
value
11.6

denoms

counts
group Id
OG000
value
166
group Id
OG001
value
82
units
Participants

description

Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019.

dispersion Type

95% Confidence Interval

groups

description
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
id
OG000
title
Anetumab Ravtansine
description
Active comparator: 30 mg/m\^2 once weekly
id
OG001
title
Vinorelbine

param Type

MEAN

population Description

The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.

reporting Status

POSTED

time Frame

Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause

title

Overall Survival (OS) - Addendum

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice