NCT03748953 · ADVERSE EVENTS

Adverse events

Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2025-03-21

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: Up to 58.4 months
Other-event reporting threshold: 5%

Ixazomib Safety Population included all participants who received at least 1 dose of ixazomib. Placebo Safety Population included all participants who received at least 1 dose of placebo. Adverse events are presented per treatment received during the course of the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ixazomib Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).	11 / 35	33 / 35	1 / 35
Placebo Participants received ixazomib placebo-matching capsules, orally, once on Days 1, 8, and 15 of each cycle until Protocol Amendment 08 was implemented (cycle length=28 days).	0 / 4	4 / 4	0 / 4

Group identifiers: EG000: Ixazomib · EG001: Placebo

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
Cardiac disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Chest discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Post procedural haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Periarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Rotator cuff syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cerebral infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Angioedema

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
MedDRA26.0
stats
group Id
EG000
num Affected
4
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Breath odour
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
12
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
6
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
35
description
Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).
id
EG000
other Num Affected
33
other Num At Risk
35
serious Num Affected
11
serious Num At Risk
35
title
Ixazomib
deaths Num Affected
0
deaths Num At Risk
4
description
Participants received ixazomib placebo-matching capsules, orally, once on Days 1, 8, and 15 of each cycle until Protocol Amendment 08 was implemented (cycle length=28 days).
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
4
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
3
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
0
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Breath odour
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
12
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
1
num At Risk
4
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
6
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Chest discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
2
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Post procedural haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Periarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Rotator cuff syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Cerebral infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA26.0
stats
group Id
EG000
num Affected
1
num At Risk
35
group Id
EG001
num Affected
0
num At Risk
4
term
Angioedema

time Frame

Up to 58.4 months

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Preserved source evidence · Not medical advice