NCT01034553 · ADVERSE EVENTS

Adverse events

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2016-05-25

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Patients bortezomib: Given IV	11 / 26	26 / 26	Not reported / Not reported

Group identifiers: EG000: All Patients

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
3
num At Risk
26
num Events
5
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Urinary tract infection

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 10
stats
group Id
EG000
num Affected
10
num At Risk
26
num Events
24
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
16
num At Risk
26
num Events
52
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
26
num Events
7
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
18
num At Risk
26
num Events
79
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
9
num At Risk
26
num Events
14
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
9
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
21
num At Risk
26
num Events
93
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fever

Complete source fields

event Groups

description
bortezomib: Given IV
id
EG000
other Num Affected
26
other Num At Risk
26
serious Num Affected
11
serious Num At Risk
26
title
All Patients

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
10
num At Risk
26
num Events
24
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
16
num At Risk
26
num Events
52
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
26
num Events
7
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
18
num At Risk
26
num Events
79
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
9
num At Risk
26
num Events
14
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
9
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
21
num At Risk
26
num Events
93
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fever

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
3
num At Risk
26
num Events
5
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Urinary tract infection

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