NCT01985126 · OUTCOME

Overall Survival

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD · Source last updated 2018-06-25

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: Approximately up to 3 years

What was measured

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.

Analysis population: All treated analysis set included all participants who received at least 1 dose of daratumumab.

Groups in this outcome

Daratumumab 8 mg/kg

Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.

Daratumumab 16 mg/kg

Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.

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
Daratumumab 8 mg/kg	18
Daratumumab 16 mg/kg	106

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 8 mg/kg	19.45	Not reported	7.72	26.81	Not reported
Daratumumab 16 mg/kg	18.60	Not reported	13.67	25.00	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
7.72
upper Limit
26.81
value
19.45
group Id
OG001
lower Limit
13.67
upper Limit
25.00
value
18.60

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
106
units
Participants

description

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

description
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
id
OG000
title
Daratumumab 8 mg/kg
description
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
id
OG001
title
Daratumumab 16 mg/kg

param Type

MEDIAN

population Description

All treated analysis set included all participants who received at least 1 dose of daratumumab.

reporting Status

POSTED

time Frame

Approximately up to 3 years

title

Overall Survival

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice