NCT01383928 · ADVERSE EVENTS

Adverse events

Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2019-03-21

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: From first study drug administration up to 30 days after the last dose (Up to approximately 2067 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 3 mg Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).	5 / 7	7 / 7	0 / 7
Phase 1: Ixazomib 3.7 mg Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).	2 / 7	7 / 7	0 / 7
Phase 2: Ixazomib 3.0 mg Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).	23 / 50	50 / 50	1 / 50

Group identifiers: EG000: Phase 1: Ixazomib 3 mg · EG001: Phase 1: Ixazomib 3.7 mg · EG002: Phase 2: Ixazomib 3.0 mg

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 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Subcutaneous abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Scrotal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Infective myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Guillain-Barre syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Syncope

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
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
23
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
20
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
20
num At Risk
50
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
50
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
6
num At Risk
50
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
5
num At Risk
50
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
5
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Epigastric discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Rectal haemorrhage

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
7
description
Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Phase 1: Ixazomib 3 mg
deaths Num Affected
0
deaths Num At Risk
7
description
Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Phase 1: Ixazomib 3.7 mg
deaths Num Affected
1
deaths Num At Risk
50
description
Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).
id
EG002
other Num Affected
50
other Num At Risk
50
serious Num Affected
23
serious Num At Risk
50
title
Phase 2: Ixazomib 3.0 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
23
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
20
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
20
num At Risk
50
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
8
num At Risk
50
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
6
num At Risk
50
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
5
num At Risk
50
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
5
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Epigastric discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Rectal haemorrhage

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
50
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
50
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Subcutaneous abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
50
term
Scrotal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Infective myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Guillain-Barre syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
50
term
Syncope

time Frame

From first study drug administration up to 30 days after the last dose (Up to approximately 2067 days)

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

Preserved source evidence · Not medical advice