NCT03128359 · ADVERSE EVENTS

Adverse events

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant · Source last updated 2024-01-09

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: Up to 2 years post-transplant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV	12 / 19	19 / 19	9 / 19
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI	6 / 19	19 / 19	0 / 19

Group identifiers: EG000: Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) · EG001: Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)

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 (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
HEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
PANCREATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
CHILLS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
FEVER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CMV VIREMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ENTEROBACTER BACTEREMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
NOCARDIA INFECTION

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
CTCAE (4.03)
stats
group Id
EG000
num Affected
19
num At Risk
19
num Events
43
group Id
EG001
num Affected
19
num At Risk
19
num Events
38
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
17
num At Risk
19
num Events
20
group Id
EG001
num Affected
9
num At Risk
19
num Events
9
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
HEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
HEMOLYTIC UREMIC SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
LEFT NECK NODULE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
LYMPH NODE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIOVENTRICULAR BLOCK FIRST DEGREE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CARDIOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CHEST PAIN CARDIAC

Complete source fields

event Groups

deaths Num Affected
9
deaths Num At Risk
19
description
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
id
EG000
other Num Affected
19
other Num At Risk
19
serious Num Affected
12
serious Num At Risk
19
title
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
deaths Num Affected
0
deaths Num At Risk
19
description
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
id
EG001
other Num Affected
19
other Num At Risk
19
serious Num Affected
6
serious Num At Risk
19
title
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
19
num At Risk
19
num Events
43
group Id
EG001
num Affected
19
num At Risk
19
num Events
38
term
ANEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
17
num At Risk
19
num Events
20
group Id
EG001
num Affected
9
num At Risk
19
num Events
9
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
HEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
HEMOLYTIC UREMIC SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
LEFT NECK NODULE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
LYMPH NODE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIAL FLUTTER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ATRIOVENTRICULAR BLOCK FIRST DEGREE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CARDIOMEGALY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CHEST PAIN CARDIAC

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
HEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
DIARRHEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
PANCREATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
19
num Events
1
term
CHILLS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
2
num At Risk
19
num Events
2
term
FEVER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
CMV VIREMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
ENTEROBACTER BACTEREMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
19
num Events
0
term
NOCARDIA INFECTION

time Frame

Up to 2 years post-transplant.

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Preserved source evidence · Not medical advice