NCT00722566 · ADVERSE EVENTS

Adverse events

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma · Source last updated 2011-10-10

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
VELCADE Subcutaneous VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.	53 / 147	112 / 147	Not reported / Not reported
VELCADE Intravenous VELCADE 1.3 mg/m\^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.	26 / 74	66 / 74	Not reported / Not reported

Group identifiers: EG000: VELCADE Subcutaneous · EG001: VELCADE Intravenous

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 (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Cardiac failure acute

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 (13.0)
stats
group Id
EG000
num Affected
29
num At Risk
147
group Id
EG001
num Affected
16
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
3
num At Risk
147
group Id
EG001
num Affected
8
num At Risk
74
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
21
num At Risk
147
group Id
EG001
num Affected
11
num At Risk
74
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
4
num At Risk
147
group Id
EG001
num Affected
7
num At Risk
74
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
6
num At Risk
147
group Id
EG001
num Affected
4
num At Risk
74
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
17
num At Risk
147
group Id
EG001
num Affected
15
num At Risk
74
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
9
num At Risk
147
group Id
EG001
num Affected
6
num At Risk
74
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
4
num At Risk
147
group Id
EG001
num Affected
6
num At Risk
74
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
7
num At Risk
74
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
22
num At Risk
147
group Id
EG001
num Affected
2
num At Risk
74
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
5
num At Risk
74
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Hyperkalaemia

Complete source fields

event Groups

description
VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
id
EG000
other Num Affected
112
other Num At Risk
147
serious Num Affected
53
serious Num At Risk
147
title
VELCADE Subcutaneous
description
VELCADE 1.3 mg/m\^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
id
EG001
other Num Affected
66
other Num At Risk
74
serious Num Affected
26
serious Num At Risk
74
title
VELCADE Intravenous

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
29
num At Risk
147
group Id
EG001
num Affected
16
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
3
num At Risk
147
group Id
EG001
num Affected
8
num At Risk
74
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
21
num At Risk
147
group Id
EG001
num Affected
11
num At Risk
74
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
4
num At Risk
147
group Id
EG001
num Affected
7
num At Risk
74
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
6
num At Risk
147
group Id
EG001
num Affected
4
num At Risk
74
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
17
num At Risk
147
group Id
EG001
num Affected
15
num At Risk
74
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
9
num At Risk
147
group Id
EG001
num Affected
6
num At Risk
74
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
4
num At Risk
147
group Id
EG001
num Affected
6
num At Risk
74
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
7
num At Risk
74
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
22
num At Risk
147
group Id
EG001
num Affected
2
num At Risk
74
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
5
num At Risk
74
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
7
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Hyperkalaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Angina Pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
0
num At Risk
147
group Id
EG001
num Affected
1
num At Risk
74
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (13.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
group Id
EG001
num Affected
0
num At Risk
74
term
Cardiac failure acute

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice