NCT02079519 · ADVERSE EVENTS

Adverse events

A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma · Source last updated 2014-07-08

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%

Intent-to-treat population: All participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bevacizumab 5 mg/kg Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.	5 / 10	0 / 10	Not reported / Not reported

Group identifiers: EG000: Bevacizumab 5 mg/kg

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
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Headache

Other reported adverse events

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

Complete source fields

description

Intent-to-treat population: All participants who received at least 1 dose of study drug.

event Groups

description
Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
id
EG000
other Num Affected
0
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Bevacizumab 5 mg/kg

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypercalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Humerus fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Headache

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Preserved source evidence · Not medical advice