NCT00436618 · ADVERSE EVENTS

Adverse events

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment · Source last updated 2019-10-22

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Relapsed Aggressive Non-Hodgkin Lymphoma Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.	38 / 114	113 / 114	Not reported / Not reported
Relapsed Indolent Non-Hodgkin Lymphoma Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.	11 / 55	55 / 55	Not reported / Not reported
Uncommon Lymphomas Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.	25 / 107	107 / 107	Not reported / Not reported

Group identifiers: EG000: Relapsed Aggressive Non-Hodgkin Lymphoma · EG001: Relapsed Indolent Non-Hodgkin Lymphoma · EG002: Uncommon Lymphomas

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 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
114
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
5
num At Risk
107
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
1
num At Risk
55
num Events
1
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
114
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
2
num At Risk
107
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Gastritis

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 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
3
num At Risk
107
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
107
num At Risk
114
num Events
426
group Id
EG001
num Affected
49
num At Risk
55
num Events
207
group Id
EG002
num Affected
103
num At Risk
107
num Events
770
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
3
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
2
num At Risk
107
num Events
2
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Ventricular tachycardia

Complete source fields

event Groups

description
Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
id
EG000
other Num Affected
113
other Num At Risk
114
serious Num Affected
38
serious Num At Risk
114
title
Relapsed Aggressive Non-Hodgkin Lymphoma
description
Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
id
EG001
other Num Affected
55
other Num At Risk
55
serious Num Affected
11
serious Num At Risk
55
title
Relapsed Indolent Non-Hodgkin Lymphoma
description
Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
id
EG002
other Num Affected
107
other Num At Risk
107
serious Num Affected
25
serious Num At Risk
107
title
Uncommon Lymphomas

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
3
num At Risk
107
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
107
num At Risk
114
num Events
426
group Id
EG001
num Affected
49
num At Risk
55
num Events
207
group Id
EG002
num Affected
103
num At Risk
107
num Events
770
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
3
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
2
num At Risk
107
num Events
2
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Ventricular tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
114
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
5
num At Risk
107
num Events
6
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
1
num At Risk
55
num Events
1
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
114
num Events
0
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
1
num At Risk
107
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
114
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
2
num At Risk
107
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
114
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
group Id
EG002
num Affected
0
num At Risk
107
num Events
0
term
Gastritis

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