NCT02290431 · ADVERSE EVENTS

Adverse events

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-18

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: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Other-event reporting threshold: 5%

Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
LBH589 + Bortezomib + Dexamethasone Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.	14 / 31	31 / 31	0 / 31

Group identifiers: EG000: LBH589 + Bortezomib + 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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Platelet count decreased

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 (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
7
num At Risk
31
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
17
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
31
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
25
num At Risk
31
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
15
num At Risk
31
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Stomatitis

Complete source fields

description

Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.

event Groups

deaths Num Affected
0
deaths Num At Risk
31
description
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
id
EG000
other Num Affected
31
other Num At Risk
31
serious Num Affected
14
serious Num At Risk
31
title
LBH589 + Bortezomib + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
7
num At Risk
31
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
17
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
31
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
25
num At Risk
31
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
15
num At Risk
31
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Platelet count decreased

time Frame

Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).

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Preserved source evidence · Not medical advice