NCT00256776 · ADVERSE EVENTS

Adverse events

MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation · Source last updated 2021-10-18

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
Thal + Dex + Velcade Velcade (Bortezomib) Thalidomide Dexamethasone Allocated to treatment (n=135) Received allocated treatment (n=135)	58 / 135	0 / 135	Not reported / Not reported
Thal + Dex Standard treatment Thalidomide Dexamethasone Allocated to treatment (n=134) Received allocated treatment (n=134)	45 / 134	0 / 134	Not reported / Not reported

Group identifiers: EG000: Thal + Dex + Velcade · EG001: Thal + Dex

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
Nervous system disorders
stats
group Id
EG000
num Affected
3
num At Risk
135
num Events
3
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
3
num At Risk
135
num Events
3
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Renal Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Respiratory Distress
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Lung Carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Vascular Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
135
num Events
15
group Id
EG001
num Affected
7
num At Risk
134
num Events
7
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
2
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Bone Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
16
num At Risk
135
num Events
21
group Id
EG001
num Affected
4
num At Risk
134
num Events
4
term
Infection

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

event Groups

description
Velcade (Bortezomib) Thalidomide Dexamethasone Allocated to treatment (n=135) Received allocated treatment (n=135)
id
EG000
other Num Affected
0
other Num At Risk
135
serious Num Affected
58
serious Num At Risk
135
title
Thal + Dex + Velcade
description
Standard treatment Thalidomide Dexamethasone Allocated to treatment (n=134) Received allocated treatment (n=134)
id
EG001
other Num Affected
0
other Num At Risk
134
serious Num Affected
45
serious Num At Risk
134
title
Thal + Dex

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
3
num At Risk
135
num Events
3
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
3
num At Risk
135
num Events
3
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Renal Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Respiratory Distress
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Lung Carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Vascular Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
135
num Events
15
group Id
EG001
num Affected
7
num At Risk
134
num Events
7
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
1
num At Risk
134
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
2
group Id
EG001
num Affected
0
num At Risk
134
num Events
0
term
Bone Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
2
num At Risk
134
num Events
2
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
16
num At Risk
135
num Events
21
group Id
EG001
num Affected
4
num At Risk
134
num Events
4
term
Infection

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Preserved source evidence · Not medical advice