NCT01830816 · ADVERSE EVENTS

Adverse events

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment · Source last updated 2019-06-10

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 signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 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
Normal Renal Function: Ixazomib Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in normal renal function participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.	3 / 20	19 / 20	Not reported / Not reported
Severe Renal Impairment: Ixazomib Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in severe renal impairment participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.	6 / 14	14 / 14	Not reported / Not reported
End-stage Renal Disease: Ixazomib Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.	3 / 7	5 / 7	Not reported / Not reported

Group identifiers: EG000: Normal Renal Function: Ixazomib · EG001: Severe Renal Impairment: Ixazomib · EG002: End-stage Renal Disease: Ixazomib

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
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in severe renal impairment arm group and is not related.
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Hypoglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in end stage renal disease arm group and is not related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in severe renal impairment arm group and is related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastrooesophageal cancer

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
16.0
stats
group Id
EG000
num Affected
8
num At Risk
20
group Id
EG001
num Affected
6
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
7
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
6
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
6
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
6
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Fatigue

Complete source fields

description

event Groups

description
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in normal renal function participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
id
EG000
other Num Affected
19
other Num At Risk
20
serious Num Affected
3
serious Num At Risk
20
title
Normal Renal Function: Ixazomib
description
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in severe renal impairment participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
id
EG001
other Num Affected
14
other Num At Risk
14
serious Num Affected
6
serious Num At Risk
14
title
Severe Renal Impairment: Ixazomib
description
Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B. Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
id
EG002
other Num Affected
5
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
End-stage Renal Disease: Ixazomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
8
num At Risk
20
group Id
EG001
num Affected
6
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
7
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
6
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
6
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
6
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in severe renal impairment arm group and is not related.
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Hypoglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in end stage renal disease arm group and is not related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
7
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with ixazomib in severe renal impairment arm group and is related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
16.0
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
7
term
Gastrooesophageal cancer

time Frame

From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)

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Preserved source evidence · Not medical advice