NCT00651937 · ADVERSE EVENTS

Adverse events

Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden · Source last updated 2020-01-14

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse event collection through the last day of active treatment day 0 (stem cell infusion) up to 30 days as outlined in the treatment plan.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Standard Dose Stem Cell Group Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.	1 / 35	1 / 35	0 / 35
High Dose Stem Cell Group Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.	0 / 40	0 / 40	0 / 40

Group identifiers: EG000: Standard Dose Stem Cell Group · EG001: High Dose Stem Cell Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
term
Graft Failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
term
Graft Failure

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
35
description
Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
id
EG000
other Num Affected
1
other Num At Risk
35
serious Num Affected
1
serious Num At Risk
35
title
Standard Dose Stem Cell Group
deaths Num Affected
0
deaths Num At Risk
40
description
Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
id
EG001
other Num Affected
0
other Num At Risk
40
serious Num Affected
0
serious Num At Risk
40
title
High Dose Stem Cell Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
term
Graft Failure

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
term
Graft Failure

time Frame

Adverse event collection through the last day of active treatment day 0 (stem cell infusion) up to 30 days as outlined in the treatment plan.

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

Preserved source evidence · Not medical advice