NCT00105001 · ADVERSE EVENTS

Adverse events

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2019-10-30

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: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (MMF and Tacrolimus) Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO	9 / 69	25 / 69	21 / 69
Arm II (MMF and Tacrolimus Alternate Schedule) Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO	8 / 71	22 / 71	24 / 71
Arm III (MMF, Tacrolimus, and Sirolimus) Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO	7 / 68	25 / 68	28 / 68

Group identifiers: EG000: Arm I (MMF and Tacrolimus) · EG001: Arm II (MMF and Tacrolimus Alternate Schedule) · EG002: Arm III (MMF, Tacrolimus, and Sirolimus)

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
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Severe hemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
3
num At Risk
71
num Events
3
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
CNS cerebrovascular ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Toxic leukoencephalopathy, infections w/ pneumonia and pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Hepatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Intestinal pneumatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
GvHD w/ infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Mucormycosis

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
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
2
num At Risk
71
num Events
2
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Colitis

Complete source fields

event Groups

deaths Num Affected
21
deaths Num At Risk
69
description
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
id
EG000
other Num Affected
25
other Num At Risk
69
serious Num Affected
9
serious Num At Risk
69
title
Arm I (MMF and Tacrolimus)
deaths Num Affected
24
deaths Num At Risk
71
description
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
id
EG001
other Num Affected
22
other Num At Risk
71
serious Num Affected
8
serious Num At Risk
71
title
Arm II (MMF and Tacrolimus Alternate Schedule)
deaths Num Affected
28
deaths Num At Risk
68
description
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
id
EG002
other Num Affected
25
other Num At Risk
68
serious Num Affected
7
serious Num At Risk
68
title
Arm III (MMF, Tacrolimus, and Sirolimus)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
2
num At Risk
71
num Events
2
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Colitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
69
num Events
2
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Severe hemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
3
num At Risk
71
num Events
3
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
CNS cerebrovascular ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Toxic leukoencephalopathy, infections w/ pneumonia and pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Hepatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
0
num At Risk
71
num Events
0
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Intestinal pneumatosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
num Events
1
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
GvHD w/ infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
1
num At Risk
68
num Events
1
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
num Events
0
group Id
EG001
num Affected
1
num At Risk
71
num Events
1
group Id
EG002
num Affected
0
num At Risk
68
num Events
0
term
Mucormycosis

time Frame

AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice