NCT01231412 · ADVERSE EVENTS

Adverse events

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant · Source last updated 2026-04-30

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: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (MMF and CSP) Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI	0 / 77	27 / 77	Not reported / Not reported
Arm II (MMF, CSP, and Sirolimus) Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI	0 / 90	26 / 90	Not reported / Not reported
Arm 0 (CSP and Sirolimus) Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011	0 / 6	3 / 6	Not reported / Not reported

Group identifiers: EG000: Arm I (MMF and CSP) · EG001: Arm II (MMF, CSP, and Sirolimus) · EG002: Arm 0 (CSP and Sirolimus)

Serious adverse events

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

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
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
77
num Events
0
group Id
EG001
num Affected
3
num At Risk
90
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
77
num Events
3
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
"Adult respiratory distress syndrome"
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
77
num Events
2
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
7
num At Risk
77
num Events
7
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
2
num At Risk
90
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
77
num Events
0
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Chronic kidney disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Colonic hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
77
num Events
4
group Id
EG001
num Affected
4
num At Risk
90
num Events
4
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Creatinine increased

Complete source fields

event Groups

description
Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
id
EG000
other Num Affected
27
other Num At Risk
77
serious Num Affected
0
serious Num At Risk
77
title
Arm I (MMF and CSP)
description
Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
id
EG001
other Num Affected
26
other Num At Risk
90
serious Num Affected
0
serious Num At Risk
90
title
Arm II (MMF, CSP, and Sirolimus)
description
Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
id
EG002
other Num Affected
3
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Arm 0 (CSP and Sirolimus)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
77
num Events
0
group Id
EG001
num Affected
3
num At Risk
90
num Events
3
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
77
num Events
3
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
"Adult respiratory distress syndrome"
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
77
num Events
2
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
7
num At Risk
77
num Events
7
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
2
num At Risk
90
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
77
num Events
0
group Id
EG001
num Affected
1
num At Risk
90
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Chronic kidney disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
77
num Events
1
group Id
EG001
num Affected
0
num At Risk
90
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Colonic hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
77
num Events
4
group Id
EG001
num Affected
4
num At Risk
90
num Events
4
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
term
Creatinine increased

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

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Preserved source evidence · Not medical advice