NCT01044745 · ADVERSE EVENTS

Adverse events

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2023-09-06

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Rituximab and Allogeneic HCT Transplant) CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy	10 / 20	16 / 20	5 / 20

Group identifiers: EG000: Treatment (Rituximab and Allogeneic HCT Transplant)

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
notes
Diarrhea
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
vomiting
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
notes
graft-versus-host disease
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Immune system disorders-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
BK virus cystitis
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
cystitis

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
20
num Events
15
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
6
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
20
num Events
14
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Parvovirus
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Infection and infestation - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
8
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
an ANC \<1000/mm3 and a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than one hour.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet.
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cellulitis
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
sinusitis

Complete source fields

event Groups

deaths Num Affected
5
deaths Num At Risk
20
description
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy
id
EG000
other Num Affected
16
other Num At Risk
20
serious Num Affected
10
serious Num At Risk
20
title
Treatment (Rituximab and Allogeneic HCT Transplant)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
20
num Events
15
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
6
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
20
num Events
14
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Parvovirus
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Infection and infestation - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
8
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
an ANC \<1000/mm3 and a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than one hour.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
A disorder characterized by redness, marked discomfort, swelling, and tingling in the palms of the hands or the soles of the feet.
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
notes
cellulitis
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
sinusitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Diarrhea
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
vomiting
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
notes
graft-versus-host disease
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Immune system disorders-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
BK virus cystitis
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
3
term
cystitis

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