NCT00589563 · ADVERSE EVENTS

Adverse events

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer · Source last updated 2014-09-10

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: 180 days
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Patients All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.	9 / 31	31 / 31	Not reported / Not reported

Group identifiers: EG000: All Patients

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Ill-defined disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Multi-organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Portal hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Abdominal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Catheter related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
16
num At Risk
31
num Events
16
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
31
num At Risk
31
num Events
31
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
6
num At Risk
31
num Events
6
term
Thrombotic microangiopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Cardiac disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Left ventricular dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Left ventricular failure

Complete source fields

event Groups

description
All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
id
EG000
other Num Affected
31
other Num At Risk
31
serious Num Affected
9
serious Num At Risk
31
title
All Patients

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
16
num At Risk
31
num Events
16
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
31
num At Risk
31
num Events
31
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Hemolysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
6
num At Risk
31
num Events
6
term
Thrombotic microangiopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Cardiac disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Left ventricular dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Left ventricular failure

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Ill-defined disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
term
Multi-organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Portal hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Abdominal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Catheter related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Colitis, infectious (e.g., Clostridium difficile)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
term
Infection

time Frame

180 days

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Preserved source evidence · Not medical advice