NCT01335685 · ADVERSE EVENTS

Adverse events

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

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 dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years
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
Arm A: Ixazomib 3.0 mg Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).	2 / 7	7 / 7	Not reported / Not reported
Arm A: Ixazomib 3.7 mg Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).	4 / 4	4 / 4	Not reported / Not reported
Arm B: Ixazomib 3.0 mg Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).	3 / 3	3 / 3	Not reported / Not reported
Arm B: Ixazomib 4.0 mg Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).	12 / 26	26 / 26	Not reported / Not reported
Arm B: Ixazomib 5.5 mg Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).	3 / 5	5 / 5	Not reported / Not reported
Arm C: Ixazomib 3.0 mg Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).	4 / 6	6 / 6	Not reported / Not reported
Arm C: Ixazomib 4.0 mg Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).	2 / 4	4 / 4	Not reported / Not reported
Arm D: Ixazomib 4.0 mg Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).	1 / 6	6 / 6	Not reported / Not reported

Group identifiers: EG000: Arm A: Ixazomib 3.0 mg · EG001: Arm A: Ixazomib 3.7 mg · EG002: Arm B: Ixazomib 3.0 mg · EG003: Arm B: Ixazomib 4.0 mg · EG004: Arm B: Ixazomib 5.5 mg · EG005: Arm C: Ixazomib 3.0 mg · EG006: Arm C: Ixazomib 4.0 mg · EG007: Arm D: Ixazomib 4.0 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
notes
One treatment-emergent death occurred in Arm B during treatment with ixazombib 4.0 mg and is not related.
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
26
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Bronchitis
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Respiratory tract infection
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Diverticulitis
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in Arm B during treatment with ixazombib 4.0 mg and is not related.
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Septic shock
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Ileus
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Subileus
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Diarrhoea
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Rectal haemorrhage
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Vomiting

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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
17
num At Risk
26
group Id
EG004
num Affected
5
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
4
group Id
EG007
num Affected
3
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
6
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
26
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
6
term
Nausea
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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
26
group Id
EG004
num Affected
4
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
6
term
Vomiting
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
2
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
6
num At Risk
26
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
6
term
Constipation
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Abdominal pain
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
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
6
term
Abdominal pain upper
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Dyspepsia
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Abdominal discomfort
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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Mouth ulceration
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Dry mouth
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Dysphagia
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Flatulence

Complete source fields

description

event Groups

description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Arm A: Ixazomib 3.0 mg
description
Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Arm A: Ixazomib 3.7 mg
description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Arm B: Ixazomib 3.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
id
EG003
other Num Affected
26
other Num At Risk
26
serious Num Affected
12
serious Num At Risk
26
title
Arm B: Ixazomib 4.0 mg
description
Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).
id
EG004
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Arm B: Ixazomib 5.5 mg
description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Arm C: Ixazomib 3.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Arm C: Ixazomib 4.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).
id
EG007
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Arm D: Ixazomib 4.0 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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
17
num At Risk
26
group Id
EG004
num Affected
5
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
4
group Id
EG007
num Affected
3
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
6
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
26
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
6
term
Nausea
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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
26
group Id
EG004
num Affected
4
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
6
term
Vomiting
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
2
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
6
num At Risk
26
group Id
EG004
num Affected
3
num At Risk
5
group Id
EG005
num Affected
3
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
6
term
Constipation
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Abdominal pain
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
1
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
6
term
Abdominal pain upper
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
2
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Dyspepsia
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Abdominal discomfort
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
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Mouth ulceration
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Dry mouth
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Dysphagia
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
6
term
Flatulence

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in Arm B during treatment with ixazombib 4.0 mg and is not related.
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
26
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Bronchitis
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Respiratory tract infection
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Diverticulitis
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in Arm B during treatment with ixazombib 4.0 mg and is not related.
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Septic shock
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
1
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Ileus
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Subileus
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Diarrhoea
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
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Rectal haemorrhage
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
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
26
group Id
EG004
num Affected
0
num At Risk
5
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
6
term
Vomiting

time Frame

From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years

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

Preserved source evidence · Not medical advice