NCT00128102 · ADVERSE EVENTS

Adverse events

Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014) · Source last updated 2020-10-26

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 ~77 months (through database cut-off date of 21-November-2011)
Other-event reporting threshold: 5%

All-Cause Mortality table includes all randomized participants. Serious AEs and other AEs tables include all randomized participants who got ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Thus Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vorinostat Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.	133 / 329	303 / 329	288 / 329
Placebo Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.	131 / 329	281 / 329	284 / 332

Group identifiers: EG000: Vorinostat · EG001: Placebo

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 8.1
stats
group Id
EG000
num Affected
10
num At Risk
329
num Events
10
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
329
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
329
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
6
num At Risk
329
num Events
7
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
329
num Events
0
group Id
EG001
num Affected
4
num At Risk
329
num Events
4
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
329
num Events
2
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Right ventricular 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 8.1
stats
group Id
EG000
num Affected
45
num At Risk
329
num Events
86
group Id
EG001
num Affected
22
num At Risk
329
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
22
num At Risk
329
num Events
46
group Id
EG001
num Affected
2
num At Risk
329
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
28
num At Risk
329
num Events
32
group Id
EG001
num Affected
17
num At Risk
329
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
80
num At Risk
329
num Events
116
group Id
EG001
num Affected
69
num At Risk
329
num Events
96
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
142
num At Risk
329
num Events
327
group Id
EG001
num Affected
58
num At Risk
329
num Events
85
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
31
num At Risk
329
num Events
35
group Id
EG001
num Affected
17
num At Risk
329
num Events
23
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
189
num At Risk
329
num Events
339
group Id
EG001
num Affected
104
num At Risk
329
num Events
162
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
131
num At Risk
329
num Events
284
group Id
EG001
num Affected
45
num At Risk
329
num Events
81
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
153
num At Risk
329
num Events
277
group Id
EG001
num Affected
128
num At Risk
329
num Events
224
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
18
num At Risk
329
num Events
26
group Id
EG001
num Affected
3
num At Risk
329
num Events
4
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
23
num At Risk
329
num Events
26
group Id
EG001
num Affected
31
num At Risk
329
num Events
38
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
38
num At Risk
329
num Events
54
group Id
EG001
num Affected
26
num At Risk
329
num Events
35
term
Pyrexia

Complete source fields

description

event Groups

deaths Num Affected
288
deaths Num At Risk
329
description
Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
303
other Num At Risk
329
serious Num Affected
133
serious Num At Risk
329
title
Vorinostat
deaths Num Affected
284
deaths Num At Risk
332
description
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
281
other Num At Risk
329
serious Num Affected
131
serious Num At Risk
329
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
45
num At Risk
329
num Events
86
group Id
EG001
num Affected
22
num At Risk
329
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
22
num At Risk
329
num Events
46
group Id
EG001
num Affected
2
num At Risk
329
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
28
num At Risk
329
num Events
32
group Id
EG001
num Affected
17
num At Risk
329
num Events
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
80
num At Risk
329
num Events
116
group Id
EG001
num Affected
69
num At Risk
329
num Events
96
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
142
num At Risk
329
num Events
327
group Id
EG001
num Affected
58
num At Risk
329
num Events
85
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
31
num At Risk
329
num Events
35
group Id
EG001
num Affected
17
num At Risk
329
num Events
23
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
189
num At Risk
329
num Events
339
group Id
EG001
num Affected
104
num At Risk
329
num Events
162
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
131
num At Risk
329
num Events
284
group Id
EG001
num Affected
45
num At Risk
329
num Events
81
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
153
num At Risk
329
num Events
277
group Id
EG001
num Affected
128
num At Risk
329
num Events
224
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
18
num At Risk
329
num Events
26
group Id
EG001
num Affected
3
num At Risk
329
num Events
4
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
23
num At Risk
329
num Events
26
group Id
EG001
num Affected
31
num At Risk
329
num Events
38
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
38
num At Risk
329
num Events
54
group Id
EG001
num Affected
26
num At Risk
329
num Events
35
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
10
num At Risk
329
num Events
10
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
329
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
329
num Events
3
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
6
num At Risk
329
num Events
7
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
1
num At Risk
329
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
329
num Events
0
group Id
EG001
num Affected
4
num At Risk
329
num Events
4
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
3
num At Risk
329
num Events
3
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
329
num Events
2
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
329
num Events
1
group Id
EG001
num Affected
0
num At Risk
329
num Events
0
term
Right ventricular failure

time Frame

Up to ~77 months (through database cut-off date of 21-November-2011)

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Preserved source evidence · Not medical advice