NCT00075478 · ADVERSE EVENTS

Adverse events

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2017-05-15

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
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation	8 / 41	34 / 41	Not reported / Not reported
Arm II (TBI, Transplant, GVHD Prophylaxis) Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation	5 / 44	20 / 44	Not reported / Not reported

Group identifiers: EG000: Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) · EG001: Arm II (TBI, Transplant, GVHD Prophylaxis)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
respiratory failure
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
seizure
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
pericardial effusion
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
thrombosis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Bactrim anaphylaxis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
44
term
Graft versus host disease with infection and organ failure
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
subdural hematoma
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
sepsis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
15
num At Risk
41
group Id
EG001
num Affected
10
num At Risk
44
term
Blood/Bone marrow
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
44
term
Cardiovascular
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Dermatology/Skin
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
44
term
Gastrointestinal
organ System
Vascular disorders
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Hemorrhage
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
5
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
44
term
Hepatic
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Metabolic/Laboratory
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
4
num At Risk
44
term
Pulmonary
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Renal/Genitourinary
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Second Malignancy

Complete source fields

event Groups

description
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
id
EG000
other Num Affected
34
other Num At Risk
41
serious Num Affected
8
serious Num At Risk
41
title
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
description
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
id
EG001
other Num Affected
20
other Num At Risk
44
serious Num Affected
5
serious Num At Risk
44
title
Arm II (TBI, Transplant, GVHD Prophylaxis)

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
15
num At Risk
41
group Id
EG001
num Affected
10
num At Risk
44
term
Blood/Bone marrow
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
5
num At Risk
44
term
Cardiovascular
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Dermatology/Skin
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
44
term
Gastrointestinal
organ System
Vascular disorders
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Hemorrhage
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
5
num At Risk
41
group Id
EG001
num Affected
3
num At Risk
44
term
Hepatic
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Metabolic/Laboratory
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
4
num At Risk
44
term
Pulmonary
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
Renal/Genitourinary
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Second Malignancy

serious Events

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
respiratory failure
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
seizure
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
pericardial effusion
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
thrombosis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
Bactrim anaphylaxis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
2
num At Risk
44
term
Graft versus host disease with infection and organ failure
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
41
group Id
EG001
num Affected
1
num At Risk
44
term
subdural hematoma
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
41
group Id
EG001
num Affected
0
num At Risk
44
term
sepsis

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Preserved source evidence · Not medical advice