NCT01801436 · ADVERSE EVENTS

Adverse events

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma · Source last updated 2013-05-16

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: Basleine up to Day 11 of Cycle 8
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bortezomib Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.	14 / 14	14 / 14	Not reported / Not reported

Group identifiers: EG000: Bortezomib

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Mouth ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
4
num At Risk
14
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Ammonia abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood albumin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood antidiuretic hormone abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood calcium increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood glucose decreased

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
3
num At Risk
14
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
3
num At Risk
14
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
7
num At Risk
14
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
8
num At Risk
14
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gingival ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
5
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Oesophageal ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
4
num At Risk
14
term
Vomiting

Complete source fields

event Groups

description
Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
id
EG000
other Num Affected
14
other Num At Risk
14
serious Num Affected
14
serious Num At Risk
14
title
Bortezomib

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
3
num At Risk
14
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
3
num At Risk
14
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
7
num At Risk
14
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
8
num At Risk
14
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gingival ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
5
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Oesophageal ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
4
num At Risk
14
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Mouth ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
4
num At Risk
14
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Ammonia abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood albumin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood antidiuretic hormone abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood calcium increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA V 10.0
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Blood glucose decreased

time Frame

Basleine up to Day 11 of Cycle 8

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Preserved source evidence · Not medical advice