NCT00635154 · ADVERSE EVENTS

Adverse events

Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma · Source last updated 2018-06-07

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
Anakinra With/Without Dexamethasone Not reported	8 / 54	53 / 54	Not reported / Not reported

Group identifiers: EG000: Anakinra With/Without 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 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Infection without neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
54
num Events
4
term
Thrombosis

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 5
stats
group Id
EG000
num Affected
3
num At Risk
54
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Anemia-Leukemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Cardiovascular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
10
num At Risk
54
num Events
19
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Ischemia/Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Middle Ear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
54
num Events
6
term
Vision-Blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
16
num At Risk
54
num Events
27
term
Dyspepsia

Complete source fields

event Groups

id
EG000
other Num Affected
53
other Num At Risk
54
serious Num Affected
8
serious Num At Risk
54
title
Anakinra With/Without Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
54
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Anemia-Leukemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Cardiovascular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
10
num At Risk
54
num Events
19
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Ischemia/Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Middle Ear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
5
num At Risk
54
num Events
6
term
Vision-Blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
16
num At Risk
54
num Events
27
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Infection without neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
1
num At Risk
54
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
2
num At Risk
54
num Events
2
term
Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5
stats
group Id
EG000
num Affected
3
num At Risk
54
num Events
4
term
Thrombosis

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Preserved source evidence · Not medical advice