NCT01009840 · ADVERSE EVENTS

Adverse events

IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients · Source last updated 2026-05-13

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
IV Busulfan Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.	18 / 30	30 / 30	Not reported / Not reported

Group identifiers: EG000: IV Busulfan

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Bacterial sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Bronchitis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Tinea versicolour

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 (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
17
num At Risk
30
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
4
num At Risk
30
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
4
num At Risk
30
term
Abdominal pain

Complete source fields

event Groups

description
Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
18
serious Num At Risk
30
title
IV Busulfan

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
17
num At Risk
30
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
4
num At Risk
30
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
4
num At Risk
30
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Bacterial sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Bronchitis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Tinea versicolour

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Preserved source evidence · Not medical advice