NCT01985126 · OUTCOME

Time to Response

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: Full Range
Time frame: Up to 14.4 Months

What was measured

Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better).

Analysis population: Responders in all treated analysis set. Only those participants with confirmed PR were analyzed.

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	2
Daratumumab 16 mg/kg	31

Reported measurements

Source class 1

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 8 mg/kg	0.99	Not reported	0.95	1.02	Not reported
Daratumumab 16 mg/kg	0.99	Not reported	0.9	5.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.95
upper Limit
1.02
value
0.99
group Id
OG001
lower Limit
0.9
upper Limit
5.6
value
0.99

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
31
units
Participants

description

Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better).

dispersion Type

Full Range

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

Responders in all treated analysis set. Only those participants with confirmed PR were analyzed.

reporting Status

POSTED

time Frame

Up to 14.4 Months

title

Time to Response

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice