Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:56 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00709592
Description: Still collecting SAEs, subjects on trial until death.
Frequency Threshold: 5
Time Frame: All events collected from first patient accrual up to day 180 or relapse for each subject on each arm.
Study: NCT00709592
Study Brief: Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A:Thymoglobulin: 1.7 mg/kg/Day 1.7 mg/kg/d thymoglobulin IV d-9 to -7 None None 7 19 19 19 View
B:Thymoglobulin: 2.5 mg/kg/Day 2.5 mg/kg/d thymoglobulin IV d-9 to d-7 None None 12 22 22 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3 View
Hepatic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
CNS toxicity SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3 View
Cardiac dysrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 3 View
Fever with out bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 3 View
Fever with Bacteremia +/- abscess SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 3 View
Intra-abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Brain abscess SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 3 View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 3 neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3 View
Lymphopenia post conditioning SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3 View
Ocular SYSTEMATIC_ASSESSMENT Eye disorders CTCAE version 3 View
Post transplant neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3 View
Bacteremia/Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 3 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 3 View