NCT00064038 · ADVERSE EVENTS

Adverse events

S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma · Source last updated 2015-03-25

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: Report through 1/13/2009 to match data reported in MS.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide and Dexamethasone Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	41 / 96	91 / 96	Not reported / Not reported
Dexamethasone Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.	21 / 94	90 / 94	Not reported / Not reported
Crossover to Rev+Dex Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	14 / 40	39 / 40	Not reported / Not reported

Group identifiers: EG000: Lenalidomide and Dexamethasone · EG001: Dexamethasone · EG002: Crossover to Rev+Dex

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
96
group Id
EG001
num Affected
2
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac General-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac-ischemia/infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
2
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Supraventricular (SVT) and nodal arrhythmia - Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Ocular/Visual-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Vision-blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Diarrhea

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
62
num At Risk
96
group Id
EG001
num Affected
63
num At Risk
94
group Id
EG002
num Affected
31
num At Risk
40
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
3
num At Risk
40
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
2
num At Risk
40
term
Ocular/Visual-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
96
group Id
EG001
num Affected
9
num At Risk
94
group Id
EG002
num Affected
5
num At Risk
40
term
Vision-blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
43
num At Risk
96
group Id
EG001
num Affected
34
num At Risk
94
group Id
EG002
num Affected
19
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
44
num At Risk
96
group Id
EG001
num Affected
29
num At Risk
94
group Id
EG002
num Affected
9
num At Risk
40
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Distention/bloating, abdominal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
8
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Dysphagia (difficulty swallowing)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
96
group Id
EG001
num Affected
12
num At Risk
94
group Id
EG002
num Affected
2
num At Risk
40
term
Heartburn/dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
96
group Id
EG001
num Affected
10
num At Risk
94
group Id
EG002
num Affected
5
num At Risk
40
term
Mucositis/stomatitis (clinical exam) - Oral cavity

Complete source fields

event Groups

description
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
91
other Num At Risk
96
serious Num Affected
41
serious Num At Risk
96
title
Lenalidomide and Dexamethasone
description
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
id
EG001
other Num Affected
90
other Num At Risk
94
serious Num Affected
21
serious Num At Risk
94
title
Dexamethasone
description
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
39
other Num At Risk
40
serious Num Affected
14
serious Num At Risk
40
title
Crossover to Rev+Dex

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
62
num At Risk
96
group Id
EG001
num Affected
63
num At Risk
94
group Id
EG002
num Affected
31
num At Risk
40
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
3
num At Risk
40
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
2
num At Risk
40
term
Ocular/Visual-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
12
num At Risk
96
group Id
EG001
num Affected
9
num At Risk
94
group Id
EG002
num Affected
5
num At Risk
40
term
Vision-blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
43
num At Risk
96
group Id
EG001
num Affected
34
num At Risk
94
group Id
EG002
num Affected
19
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
44
num At Risk
96
group Id
EG001
num Affected
29
num At Risk
94
group Id
EG002
num Affected
9
num At Risk
40
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
5
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Distention/bloating, abdominal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
8
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Dysphagia (difficulty swallowing)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
18
num At Risk
96
group Id
EG001
num Affected
12
num At Risk
94
group Id
EG002
num Affected
2
num At Risk
40
term
Heartburn/dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
96
group Id
EG001
num Affected
10
num At Risk
94
group Id
EG002
num Affected
5
num At Risk
40
term
Mucositis/stomatitis (clinical exam) - Oral cavity

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
96
group Id
EG001
num Affected
2
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac General-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Cardiac-ischemia/infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Left ventricular diastolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
2
num At Risk
94
group Id
EG002
num Affected
0
num At Risk
40
term
Supraventricular (SVT) and nodal arrhythmia - Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Ocular/Visual-Other (Specify)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Vision-blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
96
group Id
EG001
num Affected
0
num At Risk
94
group Id
EG002
num Affected
1
num At Risk
40
term
Diarrhea

time Frame

Report through 1/13/2009 to match data reported in MS.

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

Preserved source evidence · Not medical advice