NCT02112045 · OUTCOME

Overall Survival as Measured by Number of Participants Alive at Last Follow-up

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation · Source last updated 2019-11-26

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 2 years

What was measured

OS is defined as the duration from the time of transplant Day 0 to death or last follow-up.

Groups in this outcome

Experimental: Granix and High Dose Melphalan (HDM)

Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0

Control: High Dose Melphalan (HDM)

HDM intravenously (IV) on Day -2.

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
Experimental: Granix and High Dose Melphalan (HDM)	44
Control: High Dose Melphalan (HDM)	45

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	40	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	43	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.43
statistical Method
Log Rank

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.43
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
40
group Id
OG001
value
43

denoms

counts
group Id
OG000
value
44
group Id
OG001
value
45
units
Participants

description

OS is defined as the duration from the time of transplant Day 0 to death or last follow-up.

groups

description
Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
id
OG000
title
Experimental: Granix and High Dose Melphalan (HDM)
description
HDM intravenously (IV) on Day -2.
id
OG001
title
Control: High Dose Melphalan (HDM)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up to 2 years

title

Overall Survival as Measured by Number of Participants Alive at Last Follow-up

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice