NCT01023308 · ADVERSE EVENTS

Adverse events

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma · Source last updated 2020-03-17

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: Safety Set consists of all patients who received at least one dose of any component of the study treatment. 10 patients were randomized but did not receive treatment. 6 patients from PAN+BTZ+Dex and 4 patients from PBO+BTZ+Dex
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
PAN+BTZ Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.	228 / 381	379 / 381	Not reported / Not reported
PBO+BTZ Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..	157 / 377	366 / 377	Not reported / Not reported

Group identifiers: EG000: PAN+BTZ · EG001: PBO+BTZ

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
stats
group Id
EG000
num Affected
14
num At Risk
381
group Id
EG001
num Affected
3
num At Risk
377
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Monocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
381
group Id
EG001
num Affected
8
num At Risk
377
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
2
num At Risk
377
term
Angina pectoris

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
stats
group Id
EG000
num Affected
154
num At Risk
381
group Id
EG001
num Affected
125
num At Risk
377
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
61
num At Risk
381
group Id
EG001
num Affected
31
num At Risk
377
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
52
num At Risk
381
group Id
EG001
num Affected
35
num At Risk
377
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
112
num At Risk
381
group Id
EG001
num Affected
40
num At Risk
377
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
238
num At Risk
381
group Id
EG001
num Affected
150
num At Risk
377
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
381
group Id
EG001
num Affected
31
num At Risk
377
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
30
num At Risk
381
group Id
EG001
num Affected
25
num At Risk
377
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
50
num At Risk
381
group Id
EG001
num Affected
38
num At Risk
377
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
43
num At Risk
381
group Id
EG001
num Affected
36
num At Risk
377
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
101
num At Risk
381
group Id
EG001
num Affected
122
num At Risk
377
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
254
num At Risk
381
group Id
EG001
num Affected
155
num At Risk
377
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
47
num At Risk
381
group Id
EG001
num Affected
43
num At Risk
377
term
Dyspepsia

Complete source fields

event Groups

description
Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
id
EG000
other Num Affected
379
other Num At Risk
381
serious Num Affected
228
serious Num At Risk
381
title
PAN+BTZ
description
Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
id
EG001
other Num Affected
366
other Num At Risk
377
serious Num Affected
157
serious Num At Risk
377
title
PBO+BTZ

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
154
num At Risk
381
group Id
EG001
num Affected
125
num At Risk
377
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
61
num At Risk
381
group Id
EG001
num Affected
31
num At Risk
377
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
52
num At Risk
381
group Id
EG001
num Affected
35
num At Risk
377
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
112
num At Risk
381
group Id
EG001
num Affected
40
num At Risk
377
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
238
num At Risk
381
group Id
EG001
num Affected
150
num At Risk
377
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
381
group Id
EG001
num Affected
31
num At Risk
377
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
30
num At Risk
381
group Id
EG001
num Affected
25
num At Risk
377
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
50
num At Risk
381
group Id
EG001
num Affected
38
num At Risk
377
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
43
num At Risk
381
group Id
EG001
num Affected
36
num At Risk
377
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
101
num At Risk
381
group Id
EG001
num Affected
122
num At Risk
377
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
254
num At Risk
381
group Id
EG001
num Affected
155
num At Risk
377
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
47
num At Risk
381
group Id
EG001
num Affected
43
num At Risk
377
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
14
num At Risk
381
group Id
EG001
num Affected
3
num At Risk
377
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Monocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
1
num At Risk
377
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
381
group Id
EG001
num Affected
8
num At Risk
377
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
381
group Id
EG001
num Affected
0
num At Risk
377
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
381
group Id
EG001
num Affected
2
num At Risk
377
term
Angina pectoris

time Frame

Safety Set consists of all patients who received at least one dose of any component of the study treatment. 10 patients were randomized but did not receive treatment. 6 patients from PAN+BTZ+Dex and 4 patients from PBO+BTZ+Dex

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Preserved source evidence · Not medical advice