NCT00097981 · ADVERSE EVENTS

Adverse events

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2017-04-07

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: 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Thalidomide + Dexamethasone Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.	48 / 110	110 / 110	Not reported / Not reported
DOXIL + Thalidomide + Dexamethasone DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.	53 / 106	104 / 106	Not reported / Not reported

Group identifiers: EG000: Thalidomide + Dexamethasone · EG001: DOXIL + Thalidomide + Dexamethasone

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
2
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
106
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Coagulopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
106
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
106
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
106
term
Bundle Branch Block Right

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
21
num At Risk
110
group Id
EG001
num Affected
31
num At Risk
106
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
4
num At Risk
110
group Id
EG001
num Affected
21
num At Risk
106
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
5
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Cushingoid
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
9
num At Risk
110
group Id
EG001
num Affected
16
num At Risk
106
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
4
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
106
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
45
num At Risk
110
group Id
EG001
num Affected
48
num At Risk
106
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
15
num At Risk
110
group Id
EG001
num Affected
16
num At Risk
106
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
10
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
106
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Dysphagia

Complete source fields

event Groups

description
Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
id
EG000
other Num Affected
110
other Num At Risk
110
serious Num Affected
48
serious Num At Risk
110
title
Thalidomide + Dexamethasone
description
DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
id
EG001
other Num Affected
104
other Num At Risk
106
serious Num Affected
53
serious Num At Risk
106
title
DOXIL + Thalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
21
num At Risk
110
group Id
EG001
num Affected
31
num At Risk
106
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
4
num At Risk
110
group Id
EG001
num Affected
21
num At Risk
106
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
6
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
5
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Cushingoid
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
9
num At Risk
110
group Id
EG001
num Affected
16
num At Risk
106
term
Vision Blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
4
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
106
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
45
num At Risk
110
group Id
EG001
num Affected
48
num At Risk
106
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
15
num At Risk
110
group Id
EG001
num Affected
16
num At Risk
106
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
10
num At Risk
110
group Id
EG001
num Affected
6
num At Risk
106
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
7
num At Risk
106
term
Dysphagia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
2
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
106
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Coagulopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
2
num At Risk
106
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
106
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
0
num At Risk
110
group Id
EG001
num Affected
1
num At Risk
106
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
3
num At Risk
110
group Id
EG001
num Affected
3
num At Risk
106
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 8.1
stats
group Id
EG000
num Affected
1
num At Risk
110
group Id
EG001
num Affected
0
num At Risk
106
term
Bundle Branch Block Right

time Frame

2 years

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Preserved source evidence · Not medical advice