NCT00506857 · ADVERSE EVENTS

Adverse events

Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support · Source last updated 2012-02-28

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: March 2000 to December 2004 (4 years, 8 months)
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Busulfan + Fludarabine Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.	72 / 80	80 / 80	Not reported / Not reported

Group identifiers: EG000: Busulfan + Fludarabine

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
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
12
num At Risk
80
term
Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Diffuse alveolar haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
80
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
73
term
Chronic Graft versus Host Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
26
num At Risk
73
term
Acute Graft versus Host Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Elevated alanine aminotransferase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Shortness of breath

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
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
30
num At Risk
80
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
39
num At Risk
80
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
32
num At Risk
80
term
Elevated Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Hemorrhagic cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Elevated alkaline phosphate
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Altered mental status
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Occular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
6
num At Risk
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
23
num At Risk
80
term
Stomatitis/Esophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Hepatotoxicity

Complete source fields

event Groups

description
Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.
id
EG000
other Num Affected
80
other Num At Risk
80
serious Num Affected
72
serious Num At Risk
80
title
Busulfan + Fludarabine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
30
num At Risk
80
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
39
num At Risk
80
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
32
num At Risk
80
term
Elevated Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Hemorrhagic cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Elevated alkaline phosphate
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Altered mental status
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Occular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
6
num At Risk
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
23
num At Risk
80
term
Stomatitis/Esophagitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Hepatotoxicity

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
12
num At Risk
80
term
Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Diffuse alveolar haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
80
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
73
term
Chronic Graft versus Host Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
26
num At Risk
73
term
Acute Graft versus Host Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Elevated alanine aminotransferase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
80
term
Shortness of breath

time Frame

March 2000 to December 2004 (4 years, 8 months)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice