NCT00918333 · ADVERSE EVENTS

Adverse events

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma · Source last updated 2020-03-10

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: Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
Other-event reporting threshold: 0%

CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I (Panobinostat + Everolimus) Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	3 / 23	23 / 23	0 / 23
Phase II (Panobinostat + Everolimus) Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	25 / 93	92 / 93	1 / 93

Group identifiers: EG000: Phase I (Panobinostat + Everolimus) · EG001: Phase II (Panobinostat + Everolimus)

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 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
3
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Ileal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Ill-defined disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
3
num At Risk
93
num Events
4
term
Pneumonia

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 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
167
group Id
EG001
num Affected
91
num At Risk
93
num Events
349
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
15
num At Risk
23
num Events
76
group Id
EG001
num Affected
54
num At Risk
93
num Events
204
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
16
num At Risk
23
num Events
71
group Id
EG001
num Affected
52
num At Risk
93
num Events
101
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Esophageal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
93
num Events
0
term
Gingival pain

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
23
description
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
23
other Num At Risk
23
serious Num Affected
3
serious Num At Risk
23
title
Phase I (Panobinostat + Everolimus)
deaths Num Affected
1
deaths Num At Risk
93
description
Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
92
other Num At Risk
93
serious Num Affected
25
serious Num At Risk
93
title
Phase II (Panobinostat + Everolimus)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
22
num At Risk
23
num Events
167
group Id
EG001
num Affected
91
num At Risk
93
num Events
349
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
15
num At Risk
23
num Events
76
group Id
EG001
num Affected
54
num At Risk
93
num Events
204
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
16
num At Risk
23
num Events
71
group Id
EG001
num Affected
52
num At Risk
93
num Events
101
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Esophageal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
0
num At Risk
93
num Events
0
term
Gingival pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
3
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
2
num At Risk
93
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Ileal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Ill-defined disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
23
num Events
0
group Id
EG001
num Affected
1
num At Risk
93
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
group Id
EG001
num Affected
3
num At Risk
93
num Events
4
term
Pneumonia

time Frame

Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.

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Preserved source evidence · Not medical advice