NCT01496118 · ADVERSE EVENTS

Adverse events

Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2022-02-02

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 date of first treatment up to 6 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 1 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	1 / 4	4 / 4	3 / 4
Dose Level 2 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	1 / 3	3 / 3	0 / 3
Dose Level 3 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	0 / 3	3 / 3	1 / 3
Dose Level 4 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	2 / 3	3 / 3	1 / 3
Dose Level 5 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19	1 / 3	3 / 3	2 / 3
Dose Level 6 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	0 / 3	3 / 3	2 / 3
Expansion Dose Level 4 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	16 / 31	31 / 31	20 / 31
Expansion Dose Level 6 Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days	13 / 30	30 / 30	12 / 30

Group identifiers: EG000: Dose Level 1 · EG001: Dose Level 2 · EG002: Dose Level 3 · EG003: Dose Level 4 · EG004: Dose Level 5 · EG005: Dose Level 6 · EG006: Expansion Dose Level 4 · EG007: Expansion Dose Level 6

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
3
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
31
group Id
EG007
num Affected
3
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Contusion

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
23
num At Risk
31
group Id
EG007
num Affected
21
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
21
num At Risk
31
group Id
EG007
num Affected
19
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
21
num At Risk
31
group Id
EG007
num Affected
15
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
15
num At Risk
31
group Id
EG007
num Affected
16
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
16
num At Risk
31
group Id
EG007
num Affected
13
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
15
num At Risk
31
group Id
EG007
num Affected
15
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
31
group Id
EG007
num Affected
8
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
11
num At Risk
31
group Id
EG007
num Affected
10
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
6
num At Risk
31
group Id
EG007
num Affected
8
num At Risk
30
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
10
num At Risk
31
group Id
EG007
num Affected
11
num At Risk
30
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
9
num At Risk
31
group Id
EG007
num Affected
12
num At Risk
30
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
7
num At Risk
31
group Id
EG007
num Affected
7
num At Risk
30
term
Chills

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
4
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Dose Level 1
deaths Num Affected
0
deaths Num At Risk
3
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Level 2
deaths Num Affected
1
deaths Num At Risk
3
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 3
deaths Num Affected
1
deaths Num At Risk
3
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Level 4
deaths Num Affected
2
deaths Num At Risk
3
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Level 5
deaths Num Affected
2
deaths Num At Risk
3
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Level 6
deaths Num Affected
20
deaths Num At Risk
31
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG006
other Num Affected
31
other Num At Risk
31
serious Num Affected
16
serious Num At Risk
31
title
Expansion Dose Level 4
deaths Num Affected
12
deaths Num At Risk
30
description
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
id
EG007
other Num Affected
30
other Num At Risk
30
serious Num Affected
13
serious Num At Risk
30
title
Expansion Dose Level 6

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
23
num At Risk
31
group Id
EG007
num Affected
21
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
21
num At Risk
31
group Id
EG007
num Affected
19
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
21
num At Risk
31
group Id
EG007
num Affected
15
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
15
num At Risk
31
group Id
EG007
num Affected
16
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
16
num At Risk
31
group Id
EG007
num Affected
13
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
15
num At Risk
31
group Id
EG007
num Affected
15
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
31
group Id
EG007
num Affected
8
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
11
num At Risk
31
group Id
EG007
num Affected
10
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
6
num At Risk
31
group Id
EG007
num Affected
8
num At Risk
30
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
10
num At Risk
31
group Id
EG007
num Affected
11
num At Risk
30
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
9
num At Risk
31
group Id
EG007
num Affected
12
num At Risk
30
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
3
group Id
EG006
num Affected
7
num At Risk
31
group Id
EG007
num Affected
7
num At Risk
30
term
Chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
31
group Id
EG007
num Affected
1
num At Risk
30
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
3
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
31
group Id
EG007
num Affected
3
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
31
group Id
EG007
num Affected
0
num At Risk
30
term
Contusion

time Frame

From date of first treatment up to 6 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice