NCT03202628 · ADVERSE EVENTS

Adverse events

Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma · Source last updated 2023-09-21

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: 36 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) Pomalidomide: Given PO	4 / 8	8 / 8	2 / 8

Group identifiers: EG000: Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)

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 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
2
term
Thromboembolic event

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 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
33
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
6
num At Risk
8
num Events
61
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
8
num Events
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Wrist fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
13
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
6
num At Risk
8
num Events
30
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
8
num Events
23
term
Neutrophil count decreased

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
8
description
Pomalidomide: Given PO
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
33
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
6
num At Risk
8
num Events
61
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
8
num Events
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Wrist fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
13
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
6
num At Risk
8
num Events
30
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
8
num Events
23
term
Neutrophil count decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
2
term
Thromboembolic event

time Frame

36 months

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Preserved source evidence · Not medical advice