NCT02224729 · ADVERSE EVENTS

Adverse events

Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2025-04-30

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bendamustine, Bortezomib, Dexamethasone (Standard) Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: Given PO	9 / 24	24 / 24	1 / 24

Group identifiers: EG000: Bendamustine, Bortezomib, Dexamethasone (Standard)

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
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Joint Function Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Death- Anaphylactic Shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Gout
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
3
term
Syncope episode
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Failure to Thrive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Allergic Reaction

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
stats
group Id
EG000
num Affected
7
num At Risk
24
num Events
9
term
Alkaline Phosphate increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Abdominal cramping
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
12
num At Risk
24
num Events
16
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
AST increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
8
num At Risk
24
num Events
8
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
24
num Events
4
term
Change in taste
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Confusion

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
24
description
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses. Bendamustine hydrochloride: Given IV Bortezomib: Given SC Dexamethasone: Given PO
id
EG000
other Num Affected
24
other Num At Risk
24
serious Num Affected
9
serious Num At Risk
24
title
Bendamustine, Bortezomib, Dexamethasone (Standard)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
24
num Events
9
term
Alkaline Phosphate increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Abdominal cramping
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
12
num At Risk
24
num Events
16
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
AST increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
8
num At Risk
24
num Events
8
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Bruising
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
24
num Events
4
term
Change in taste
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Confusion

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Joint Function Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Death- Anaphylactic Shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Gout
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
3
term
Syncope episode
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Failure to Thrive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Allergic Reaction

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Preserved source evidence · Not medical advice