NCT00833560 · ADVERSE EVENTS

Adverse events

A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy · Source last updated 2014-11-21

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 date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cyclophosphamide + Bortezomib + Dexamethasone Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles	103 / 395	392 / 395	Not reported / Not reported

Group identifiers: EG000: Cyclophosphamide + Bortezomib + Dexamethasone

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
MedDRA version 9.1
stats
group Id
EG000
num Affected
15
num At Risk
395
num Events
16
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
2
num At Risk
395
num Events
2
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bacterial sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchitis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Encephalitis herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Endocarditis bacterial

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
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
79
num At Risk
395
num Events
105
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
76
num At Risk
395
num Events
85
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
56
num At Risk
395
num Events
70
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
41
num At Risk
395
num Events
46
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
28
num At Risk
395
num Events
32
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
28
num At Risk
395
num Events
33
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
63
num At Risk
395
num Events
75
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
54
num At Risk
395
num Events
62
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
51
num At Risk
395
num Events
68
term
Polyneuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
48
num At Risk
395
num Events
55
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
27
num At Risk
395
num Events
30
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
20
num At Risk
395
num Events
20
term
Dysgeusia

Complete source fields

event Groups

description
Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
id
EG000
other Num Affected
392
other Num At Risk
395
serious Num Affected
103
serious Num At Risk
395
title
Cyclophosphamide + Bortezomib + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
79
num At Risk
395
num Events
105
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
76
num At Risk
395
num Events
85
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
56
num At Risk
395
num Events
70
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
41
num At Risk
395
num Events
46
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
28
num At Risk
395
num Events
32
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
28
num At Risk
395
num Events
33
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
63
num At Risk
395
num Events
75
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
54
num At Risk
395
num Events
62
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
51
num At Risk
395
num Events
68
term
Polyneuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
48
num At Risk
395
num Events
55
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
27
num At Risk
395
num Events
30
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 9.1
stats
group Id
EG000
num Affected
20
num At Risk
395
num Events
20
term
Dysgeusia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
15
num At Risk
395
num Events
16
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
3
num At Risk
395
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
2
num At Risk
395
num Events
2
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bacterial sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchitis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Encephalitis herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 9.1
stats
group Id
EG000
num Affected
1
num At Risk
395
num Events
1
term
Endocarditis bacterial

time Frame

From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.

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Preserved source evidence · Not medical advice