NCT01499147 · ADVERSE EVENTS

Adverse events

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies · Source last updated 2018-11-08

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: 365 days post-transplant
Other-event reporting threshold: 0%

REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Participants With Extra-hematological Toxicities We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.	8 / 30	0 / 30	Not reported / Not reported
FluBu Participants With Extra-hematological Toxicities We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.	5 / 18	0 / 18	Not reported / Not reported
FluMel Participants With Extra-hematological Toxicities We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.	3 / 12	0 / 12	Not reported / Not reported

Group identifiers: EG000: Participants With Extra-hematological Toxicities · EG001: FluBu Participants With Extra-hematological Toxicities · EG002: FluMel Participants With Extra-hematological Toxicities

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
Gastrointestinal disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
5
num At Risk
30
num Events
5
group Id
EG001
num Affected
3
num At Risk
18
num Events
3
group Id
EG002
num Affected
2
num At Risk
12
num Events
2
term
CMV reactivation

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
Hepatobiliary disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Veno-occlusive disease

Complete source fields

description

REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)

event Groups

description
We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.
id
EG000
other Num Affected
0
other Num At Risk
30
serious Num Affected
8
serious Num At Risk
30
title
Participants With Extra-hematological Toxicities
description
We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.
id
EG001
other Num Affected
0
other Num At Risk
18
serious Num Affected
5
serious Num At Risk
18
title
FluBu Participants With Extra-hematological Toxicities
description
We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
id
EG002
other Num Affected
0
other Num At Risk
12
serious Num Affected
3
serious Num At Risk
12
title
FluMel Participants With Extra-hematological Toxicities

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Veno-occlusive disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
group Id
EG001
num Affected
2
num At Risk
18
num Events
2
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
Bearman criteria
stats
group Id
EG000
num Affected
5
num At Risk
30
num Events
5
group Id
EG001
num Affected
3
num At Risk
18
num Events
3
group Id
EG002
num Affected
2
num At Risk
12
num Events
2
term
CMV reactivation

time Frame

365 days post-transplant

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Preserved source evidence · Not medical advice