NCT00103506 · ADVERSE EVENTS

Adverse events

Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma · Source last updated 2015-10-19

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%

Safety population included all the participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Velcade (Bortezomib) Monotherapy Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.	105 / 318	299 / 318	Not reported / Not reported
Doxil/Caelyx Plus Velcade (Bortezomib) Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.	120 / 318	313 / 318	Not reported / Not reported

Group identifiers: EG000: Velcade (Bortezomib) Monotherapy · EG001: Doxil/Caelyx Plus Velcade (Bortezomib)

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 9.0
stats
group Id
EG000
num Affected
4
num At Risk
318
group Id
EG001
num Affected
3
num At Risk
318
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
5
num At Risk
318
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
318
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
318
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
9
num At Risk
318
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Atrial Flutter

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 9.0
stats
group Id
EG000
num Affected
67
num At Risk
318
group Id
EG001
num Affected
80
num At Risk
318
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
23
num At Risk
318
group Id
EG001
num Affected
28
num At Risk
318
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
71
num At Risk
318
group Id
EG001
num Affected
113
num At Risk
318
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
89
num At Risk
318
group Id
EG001
num Affected
104
num At Risk
318
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
17
num At Risk
318
group Id
EG001
num Affected
24
num At Risk
318
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
23
num At Risk
318
group Id
EG001
num Affected
32
num At Risk
318
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
13
num At Risk
318
group Id
EG001
num Affected
24
num At Risk
318
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
98
num At Risk
318
group Id
EG001
num Affected
99
num At Risk
318
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
122
num At Risk
318
group Id
EG001
num Affected
142
num At Risk
318
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
13
num At Risk
318
group Id
EG001
num Affected
27
num At Risk
318
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
125
num At Risk
318
group Id
EG001
num Affected
152
num At Risk
318
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
11
num At Risk
318
group Id
EG001
num Affected
55
num At Risk
318
term
Stomatitis

Complete source fields

description

Safety population included all the participants who received at least one dose of study drug.

event Groups

description
Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
id
EG000
other Num Affected
299
other Num At Risk
318
serious Num Affected
105
serious Num At Risk
318
title
Velcade (Bortezomib) Monotherapy
description
Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
id
EG001
other Num Affected
313
other Num At Risk
318
serious Num Affected
120
serious Num At Risk
318
title
Doxil/Caelyx Plus Velcade (Bortezomib)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
67
num At Risk
318
group Id
EG001
num Affected
80
num At Risk
318
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
23
num At Risk
318
group Id
EG001
num Affected
28
num At Risk
318
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
71
num At Risk
318
group Id
EG001
num Affected
113
num At Risk
318
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
89
num At Risk
318
group Id
EG001
num Affected
104
num At Risk
318
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
17
num At Risk
318
group Id
EG001
num Affected
24
num At Risk
318
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
23
num At Risk
318
group Id
EG001
num Affected
32
num At Risk
318
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
13
num At Risk
318
group Id
EG001
num Affected
24
num At Risk
318
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
98
num At Risk
318
group Id
EG001
num Affected
99
num At Risk
318
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
122
num At Risk
318
group Id
EG001
num Affected
142
num At Risk
318
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
13
num At Risk
318
group Id
EG001
num Affected
27
num At Risk
318
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
125
num At Risk
318
group Id
EG001
num Affected
152
num At Risk
318
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
11
num At Risk
318
group Id
EG001
num Affected
55
num At Risk
318
term
Stomatitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
4
num At Risk
318
group Id
EG001
num Affected
3
num At Risk
318
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
5
num At Risk
318
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
318
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
2
num At Risk
318
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
9
num At Risk
318
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
1
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
2
num At Risk
318
group Id
EG001
num Affected
0
num At Risk
318
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 9.0
stats
group Id
EG000
num Affected
0
num At Risk
318
group Id
EG001
num Affected
1
num At Risk
318
term
Atrial Flutter

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Preserved source evidence · Not medical advice