NCT01102426 · OUTCOME

Overall Survival

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma · Source last updated 2020-11-10

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 to the death due to any cause,assessed up to 5 years

What was measured

Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact

Analysis population: All Randomized Patients

Groups in this outcome

Plitidepsin+Dexamethasone

plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.

Dexamethasone

dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four 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
Plitidepsin+Dexamethasone	171
Dexamethasone	84

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Plitidepsin+Dexamethasone	11.6	Not reported	9.2	16.1	Not reported
Dexamethasone	8.9	Not reported	6.0	15.4	Not reported

Source statistical analyses

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

ci Lower Limit
0.596
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.067
group Description
Pre-specified
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.1261
p Value Comment
Cox regression HR: p=0.1273
param Type
Hazard Ratio (HR)
param Value
0.797
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.596
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.067
group Description
Pre-specified
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.1261
p Value Comment
Cox regression HR: p=0.1273
param Type
Hazard Ratio (HR)
param Value
0.797
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
9.2
upper Limit
16.1
value
11.6
group Id
OG001
lower Limit
6.0
upper Limit
15.4
value
8.9

denoms

counts
group Id
OG000
value
171
group Id
OG001
value
84
units
Participants

description

Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact

dispersion Type

95% Confidence Interval

groups

description
plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
id
OG000
title
Plitidepsin+Dexamethasone
description
dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
id
OG001
title
Dexamethasone

param Type

MEDIAN

population Description

All Randomized Patients

reporting Status

POSTED

time Frame

From randomization to the death due to any cause,assessed up to 5 years

title

Overall Survival

type

SECONDARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice