NCT01217957 · ADVERSE EVENTS

Adverse events

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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 787 days
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Ixazomib + Lenalidomide + Dexamethasone In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.	8 / 15	15 / 15	Not reported / Not reported
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.	20 / 50	50 / 50	Not reported / Not reported

Group identifiers: EG000: Phase 1: Ixazomib + Lenalidomide + Dexamethasone · EG001: Phase 2: Ixazomib 4.0 mg + Lenalidomide + 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
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
4
num At Risk
50
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Bone abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Postoperative wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in the Phase 2: Ixazomib 4 mg treatment arm and is related to the full regimen (lenalidomide, dexamethasone, and ixazomib).
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Pneumonia respiratory syncytial viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Abdominal hernia

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 (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
7
num At Risk
50
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
7
num At Risk
50
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
16
num At Risk
50
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
50
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Deafness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
50
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
4
num At Risk
50
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
6
num At Risk
50
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
50
term
Abdominal distension

Complete source fields

description

event Groups

description
In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
15
other Num At Risk
15
serious Num Affected
8
serious Num At Risk
15
title
Phase 1: Ixazomib + Lenalidomide + Dexamethasone
description
In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
50
other Num At Risk
50
serious Num Affected
20
serious Num At Risk
50
title
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
7
num At Risk
50
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
7
num At Risk
50
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
16
num At Risk
50
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
50
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Deafness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
50
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
4
num At Risk
50
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
6
num At Risk
50
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Visual impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
50
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
4
num At Risk
50
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Bone abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Postoperative wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in the Phase 2: Ixazomib 4 mg treatment arm and is related to the full regimen (lenalidomide, dexamethasone, and ixazomib).
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Pneumonia respiratory syncytial viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
50
term
Abdominal hernia

time Frame

Up to 787 days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice