NCT00773747 · ADVERSE EVENTS

Adverse events

Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN) · Source last updated 2021-04-30

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: Up to 722 days.
Other-event reporting threshold: 5%

Adverse events were reported for the All Participants as Treated Population that included all randomized participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vorinostat + Bortezomib Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.	130 / 315	312 / 315	Not reported / Not reported
Placebo + Bortezomib Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.	138 / 320	306 / 320	Not reported / Not reported

Group identifiers: EG000: Vorinostat + Bortezomib · EG001: Placebo + 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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
315
num Events
4
group Id
EG001
num Affected
2
num At Risk
320
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
315
num Events
4
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
315
num Events
2
group Id
EG001
num Affected
1
num At Risk
320
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
9
num At Risk
315
num Events
13
group Id
EG001
num Affected
3
num At Risk
320
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
315
num Events
0
group Id
EG001
num Affected
1
num At Risk
320
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
2
num At Risk
320
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
315
num Events
2
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiopulmonary failure

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
MedDRA 14.0
stats
group Id
EG000
num Affected
91
num At Risk
315
num Events
198
group Id
EG001
num Affected
79
num At Risk
320
num Events
164
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
42
num At Risk
315
num Events
121
group Id
EG001
num Affected
32
num At Risk
320
num Events
122
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
112
num At Risk
315
num Events
406
group Id
EG001
num Affected
95
num At Risk
320
num Events
300
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
172
num At Risk
315
num Events
749
group Id
EG001
num Affected
106
num At Risk
320
num Events
384
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
8
num At Risk
315
num Events
11
group Id
EG001
num Affected
17
num At Risk
320
num Events
21
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
22
num At Risk
315
num Events
37
group Id
EG001
num Affected
27
num At Risk
320
num Events
40
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
26
num At Risk
315
num Events
42
group Id
EG001
num Affected
13
num At Risk
320
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
64
num At Risk
315
num Events
91
group Id
EG001
num Affected
86
num At Risk
320
num Events
132
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
194
num At Risk
315
num Events
604
group Id
EG001
num Affected
133
num At Risk
320
num Events
275
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
24
num At Risk
315
num Events
38
group Id
EG001
num Affected
26
num At Risk
320
num Events
40
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
193
num At Risk
315
num Events
457
group Id
EG001
num Affected
126
num At Risk
320
num Events
247
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
140
num At Risk
315
num Events
280
group Id
EG001
num Affected
80
num At Risk
320
num Events
127
term
Vomiting

Complete source fields

description

Adverse events were reported for the All Participants as Treated Population that included all randomized participants who received at least one dose of study treatment.

event Groups

description
Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
id
EG000
other Num Affected
312
other Num At Risk
315
serious Num Affected
130
serious Num At Risk
315
title
Vorinostat + Bortezomib
description
Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
id
EG001
other Num Affected
306
other Num At Risk
320
serious Num Affected
138
serious Num At Risk
320
title
Placebo + Bortezomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
91
num At Risk
315
num Events
198
group Id
EG001
num Affected
79
num At Risk
320
num Events
164
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
42
num At Risk
315
num Events
121
group Id
EG001
num Affected
32
num At Risk
320
num Events
122
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
112
num At Risk
315
num Events
406
group Id
EG001
num Affected
95
num At Risk
320
num Events
300
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
172
num At Risk
315
num Events
749
group Id
EG001
num Affected
106
num At Risk
320
num Events
384
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
8
num At Risk
315
num Events
11
group Id
EG001
num Affected
17
num At Risk
320
num Events
21
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
22
num At Risk
315
num Events
37
group Id
EG001
num Affected
27
num At Risk
320
num Events
40
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
26
num At Risk
315
num Events
42
group Id
EG001
num Affected
13
num At Risk
320
num Events
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
64
num At Risk
315
num Events
91
group Id
EG001
num Affected
86
num At Risk
320
num Events
132
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
194
num At Risk
315
num Events
604
group Id
EG001
num Affected
133
num At Risk
320
num Events
275
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
24
num At Risk
315
num Events
38
group Id
EG001
num Affected
26
num At Risk
320
num Events
40
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
193
num At Risk
315
num Events
457
group Id
EG001
num Affected
126
num At Risk
320
num Events
247
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
140
num At Risk
315
num Events
280
group Id
EG001
num Affected
80
num At Risk
320
num Events
127
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
315
num Events
4
group Id
EG001
num Affected
2
num At Risk
320
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
315
num Events
4
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
315
num Events
2
group Id
EG001
num Affected
1
num At Risk
320
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
9
num At Risk
315
num Events
13
group Id
EG001
num Affected
3
num At Risk
320
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
315
num Events
0
group Id
EG001
num Affected
1
num At Risk
320
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
2
num At Risk
320
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
315
num Events
2
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
315
num Events
1
group Id
EG001
num Affected
0
num At Risk
320
num Events
0
term
Cardiopulmonary failure

time Frame

Up to 722 days.

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Preserved source evidence · Not medical advice