NCT00425555 · ADVERSE EVENTS

Adverse events

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20

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: From Start of the Study up to 7 years approximately
Other-event reporting threshold: 5%

The analysis was performed on Safety analysis population (SAP) consisted of all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bexarotene Exposed Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.	33 / 79	77 / 79	3 / 79
Bexarotene Naive Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.	23 / 60	59 / 60	3 / 60

Group identifiers: EG000: Bexarotene Exposed · EG001: Bexarotene Naive

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 (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
2
num At Risk
60
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
79
group Id
EG001
num Affected
2
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Coronary artery insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Tachycardia

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 (Unspecified)
stats
group Id
EG000
num Affected
17
num At Risk
79
group Id
EG001
num Affected
6
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
4
num At Risk
60
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
14
num At Risk
79
group Id
EG001
num Affected
10
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
40
num At Risk
79
group Id
EG001
num Affected
23
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
5
num At Risk
60
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
79
group Id
EG001
num Affected
4
num At Risk
60
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
79
group Id
EG001
num Affected
5
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
3
num At Risk
60
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
79
group Id
EG001
num Affected
11
num At Risk
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
45
num At Risk
79
group Id
EG001
num Affected
38
num At Risk
60
term
Diarrhoea

Complete source fields

description

The analysis was performed on Safety analysis population (SAP) consisted of all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.

event Groups

deaths Num Affected
3
deaths Num At Risk
79
description
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.
id
EG000
other Num Affected
77
other Num At Risk
79
serious Num Affected
33
serious Num At Risk
79
title
Bexarotene Exposed
deaths Num Affected
3
deaths Num At Risk
60
description
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred.
id
EG001
other Num Affected
59
other Num At Risk
60
serious Num Affected
23
serious Num At Risk
60
title
Bexarotene Naive

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
17
num At Risk
79
group Id
EG001
num Affected
6
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
4
num At Risk
60
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
14
num At Risk
79
group Id
EG001
num Affected
10
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
40
num At Risk
79
group Id
EG001
num Affected
23
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
5
num At Risk
60
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
79
group Id
EG001
num Affected
4
num At Risk
60
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
79
group Id
EG001
num Affected
5
num At Risk
60
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
79
group Id
EG001
num Affected
3
num At Risk
60
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
79
group Id
EG001
num Affected
11
num At Risk
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
45
num At Risk
79
group Id
EG001
num Affected
38
num At Risk
60
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
2
num At Risk
60
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
79
group Id
EG001
num Affected
2
num At Risk
60
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
79
group Id
EG001
num Affected
1
num At Risk
60
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Coronary artery insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
79
group Id
EG001
num Affected
0
num At Risk
60
term
Tachycardia

time Frame

From Start of the Study up to 7 years approximately

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice