NCT01215344 · ADVERSE EVENTS

Adverse events

First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade · Source last updated 2018-05-15

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
VRD (VELCADE, Lenalidomide, Dexamethasone) VELCADE, Lenalidomide, Dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle Lenalidomide: 25 mg by mouth on days 1-4 of each cycle Dexamethasone: 20 mg the day before and the day after receiving VELCADE DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.	9 / 33	31 / 33	Not reported / Not reported
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone) VELCADE, liposomal doxorubicin, dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4	0 / 3	3 / 3	Not reported / Not reported

Group identifiers: EG000: VRD (VELCADE, Lenalidomide, Dexamethasone) · EG001: VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)

Serious adverse events

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

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Decreased hemoglobin
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastritis
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Infection with normal ANC - Esophagus
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
dehydration
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Urinary Tract Infection
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Potassium low
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastric Schwannoma
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fever
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Shortness of breath
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Acute respiratory failure
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pneumonia

Other reported adverse events

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

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
14
num At Risk
33
num Events
21
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
12
num At Risk
33
num Events
15
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
9
num At Risk
33
num Events
12
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
33
num Events
7
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
term
Mucositis/stomatitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
33
num Events
6
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anorexia
organ System
General disorders
stats
group Id
EG000
num Affected
5
num At Risk
33
num Events
6
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
33
num Events
4
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastritis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Heartburn
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Taste alteration
organ System
General disorders
stats
group Id
EG000
num Affected
15
num At Risk
33
num Events
21
group Id
EG001
num Affected
3
num At Risk
3
num Events
5
term
Fatigue
organ System
General disorders
stats
group Id
EG000
num Affected
8
num At Risk
33
num Events
8
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Fever
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
3
num At Risk
33
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
term
Insomnia

Complete source fields

event Groups

description
VELCADE, Lenalidomide, Dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle Lenalidomide: 25 mg by mouth on days 1-4 of each cycle Dexamethasone: 20 mg the day before and the day after receiving VELCADE DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
id
EG000
other Num Affected
31
other Num At Risk
33
serious Num Affected
9
serious Num At Risk
33
title
VRD (VELCADE, Lenalidomide, Dexamethasone)
description
VELCADE, liposomal doxorubicin, dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
VDD (VELCADE, Liposomal Doxorubicin, Dexamethasone)

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
14
num At Risk
33
num Events
21
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
12
num At Risk
33
num Events
15
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
9
num At Risk
33
num Events
12
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
33
num Events
7
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
term
Mucositis/stomatitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
33
num Events
6
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anorexia
organ System
General disorders
stats
group Id
EG000
num Affected
5
num At Risk
33
num Events
6
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
33
num Events
4
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastritis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Heartburn
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Taste alteration
organ System
General disorders
stats
group Id
EG000
num Affected
15
num At Risk
33
num Events
21
group Id
EG001
num Affected
3
num At Risk
3
num Events
5
term
Fatigue
organ System
General disorders
stats
group Id
EG000
num Affected
8
num At Risk
33
num Events
8
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Fever
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
3
num At Risk
33
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
term
Insomnia

serious Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Decreased hemoglobin
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastritis
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Infection with normal ANC - Esophagus
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
dehydration
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Urinary Tract Infection
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Potassium low
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastric Schwannoma
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fever
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Shortness of breath
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Acute respiratory failure
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pneumonia

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