NCT00813150 · ADVERSE EVENTS

Adverse events

Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma · Source last updated 2014-08-15

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: Approximately 5 years
Other-event reporting threshold: 2%

A total of 96 patients were randomly allocated to the 2 treatment arms in the study. 93 patients received at least 1 dose of study drug and were included in the safety analysis. Of these follow-up data on treatment response was not available for 3 patients, so, they were excluded from the Intent-to-treat analysis data set.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vd (Bortezomib + Dexamethasone) Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.	15 / 46	43 / 46	Not reported / Not reported
Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide) Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.	14 / 47	46 / 47	Not reported / Not reported

Group identifiers: EG000: Vd (Bortezomib + Dexamethasone) · EG001: Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)

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 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
4
group Id
EG001
num Affected
4
num At Risk
47
num Events
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Varicella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Viral upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Diverticulum

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 version 12.0
stats
group Id
EG000
num Affected
17
num At Risk
46
num Events
87
group Id
EG001
num Affected
18
num At Risk
47
num Events
83
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
12
num At Risk
46
num Events
22
group Id
EG001
num Affected
6
num At Risk
47
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
10
group Id
EG001
num Affected
7
num At Risk
47
num Events
12
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
7
group Id
EG001
num Affected
1
num At Risk
47
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
11
num At Risk
46
num Events
14
group Id
EG001
num Affected
17
num At Risk
47
num Events
28
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
10
num At Risk
46
num Events
16
group Id
EG001
num Affected
13
num At Risk
47
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
7
num At Risk
46
num Events
7
group Id
EG001
num Affected
11
num At Risk
47
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
3
num At Risk
46
num Events
5
group Id
EG001
num Affected
5
num At Risk
47
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
5
group Id
EG001
num Affected
3
num At Risk
47
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
3
num At Risk
47
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
5
num At Risk
47
num Events
5
term
Stomatitis

Complete source fields

description

event Groups

description
Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
id
EG000
other Num Affected
43
other Num At Risk
46
serious Num Affected
15
serious Num At Risk
46
title
Vd (Bortezomib + Dexamethasone)
description
Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
id
EG001
other Num Affected
46
other Num At Risk
47
serious Num Affected
14
serious Num At Risk
47
title
Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
17
num At Risk
46
num Events
87
group Id
EG001
num Affected
18
num At Risk
47
num Events
83
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
12
num At Risk
46
num Events
22
group Id
EG001
num Affected
6
num At Risk
47
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
10
group Id
EG001
num Affected
7
num At Risk
47
num Events
12
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
7
group Id
EG001
num Affected
1
num At Risk
47
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
11
num At Risk
46
num Events
14
group Id
EG001
num Affected
17
num At Risk
47
num Events
28
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
10
num At Risk
46
num Events
16
group Id
EG001
num Affected
13
num At Risk
47
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
7
num At Risk
46
num Events
7
group Id
EG001
num Affected
11
num At Risk
47
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
3
num At Risk
46
num Events
5
group Id
EG001
num Affected
5
num At Risk
47
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
5
group Id
EG001
num Affected
3
num At Risk
47
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
3
num At Risk
47
num Events
4
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
5
num At Risk
47
num Events
5
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
4
num At Risk
46
num Events
4
group Id
EG001
num Affected
4
num At Risk
47
num Events
4
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
0
num At Risk
47
num Events
0
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Varicella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Viral upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 12.0
stats
group Id
EG000
num Affected
0
num At Risk
46
num Events
0
group Id
EG001
num Affected
1
num At Risk
47
num Events
1
term
Diverticulum

time Frame

Approximately 5 years

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Preserved source evidence · Not medical advice