NCT00908232 · ADVERSE EVENTS

Adverse events

Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD · Source last updated 2015-01-15

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: From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.
Other-event reporting threshold: 5%

Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Complete to Partial Response: Bortezomib + Dexamethasone Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8	59 / 144	137 / 144	Not reported / Not reported
Stable Disease After 4 Cycles: VD, VDC, VDL Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8	6 / 19	19 / 19	Not reported / Not reported

Group identifiers: EG000: Complete to Partial Response: Bortezomib + Dexamethasone · EG001: Stable Disease After 4 Cycles: VD, VDC, VDL

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
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Renal failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Renal failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Urinary Retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Pulmonary Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Acute Pulmonary Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Acute Respiratory Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Dyspnoea exertional
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Pulmonary fibrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Sleep Apnoea Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Upper Respiratory Tract Inflammation

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
52
num At Risk
144
num Events
216
group Id
EG001
num Affected
8
num At Risk
19
num Events
22
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
29
num At Risk
144
num Events
79
group Id
EG001
num Affected
6
num At Risk
19
num Events
14
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
10
num At Risk
144
num Events
20
group Id
EG001
num Affected
2
num At Risk
19
num Events
7
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
37
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
10
group Id
EG001
num Affected
2
num At Risk
19
num Events
3
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
144
num Events
81
group Id
EG001
num Affected
5
num At Risk
19
num Events
6
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
144
num Events
66
group Id
EG001
num Affected
5
num At Risk
19
num Events
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
16
num At Risk
144
num Events
23
group Id
EG001
num Affected
3
num At Risk
19
num Events
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
8
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
11
num At Risk
144
num Events
15
group Id
EG001
num Affected
1
num At Risk
19
num Events
2
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
10
num At Risk
144
num Events
11
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
144
num Events
49
group Id
EG001
num Affected
5
num At Risk
19
num Events
11
term
Oedema Peripheral

Complete source fields

description

event Groups

description
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
id
EG000
other Num Affected
137
other Num At Risk
144
serious Num Affected
59
serious Num At Risk
144
title
Complete to Partial Response: Bortezomib + Dexamethasone
description
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
id
EG001
other Num Affected
19
other Num At Risk
19
serious Num Affected
6
serious Num At Risk
19
title
Stable Disease After 4 Cycles: VD, VDC, VDL

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
52
num At Risk
144
num Events
216
group Id
EG001
num Affected
8
num At Risk
19
num Events
22
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
29
num At Risk
144
num Events
79
group Id
EG001
num Affected
6
num At Risk
19
num Events
14
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
10
num At Risk
144
num Events
20
group Id
EG001
num Affected
2
num At Risk
19
num Events
7
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
37
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
10
group Id
EG001
num Affected
2
num At Risk
19
num Events
3
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
144
num Events
81
group Id
EG001
num Affected
5
num At Risk
19
num Events
6
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
144
num Events
66
group Id
EG001
num Affected
5
num At Risk
19
num Events
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
16
num At Risk
144
num Events
23
group Id
EG001
num Affected
3
num At Risk
19
num Events
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
num Events
8
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
11
num At Risk
144
num Events
15
group Id
EG001
num Affected
1
num At Risk
19
num Events
2
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
10
num At Risk
144
num Events
11
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
144
num Events
49
group Id
EG001
num Affected
5
num At Risk
19
num Events
11
term
Oedema Peripheral

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Renal failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Renal failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Urinary Retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Pulmonary Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Acute Pulmonary Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Acute Respiratory Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Dyspnoea exertional
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Pulmonary fibrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Sleep Apnoea Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
Upper Respiratory Tract Inflammation

time Frame

From signing of informed consent until 30 days after the last dose of study medication (approximately 7 months) or longer if considered related to study medication.

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