NCT00573391 · ADVERSE EVENTS

Adverse events

Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 · Source last updated 2011-08-12

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Velcade, Thalidomide, and Dexamethasone Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11	1 / 5	2 / 5	Not reported / Not reported
VMD With Melphalan Dose Escalation VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10	1 / 5	0 / 5	Not reported / Not reported

Group identifiers: EG000: Velcade, Thalidomide, and Dexamethasone · EG001: VMD With Melphalan Dose Escalation

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
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
fever

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
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
secondary pulmonary hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
pneumonia

Complete source fields

event Groups

description
Velcade 1.0 mg/m\^2 Velcade 1.3 mg/m\^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m\^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
id
EG000
other Num Affected
2
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Velcade, Thalidomide, and Dexamethasone
description
VMD: Velcade 1.3 mg/m\^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m\^2) Melphalan 4 (6, 8, 10) mg/m\^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10
id
EG001
other Num Affected
0
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
VMD With Melphalan Dose Escalation

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
secondary pulmonary hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
pneumonia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
fever

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

Preserved source evidence · Not medical advice