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 @ 3:25 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT00744692
Description: Adverse events that were expected and non-serious were not collected in this study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00744692
Study Brief: Reduced Intensity Conditioning for Umbilical Cord Blood Transplant in Pediatric Patients With Non-Malignant Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RIC Cord Blood Transplant Reduced Intensity Conditioning for Umbilical Cord Blood Transplant Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant Reduced Intensity Conditioning None None 18 22 0 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory Distress None Respiratory, thoracic and mediastinal disorders None View
Fever None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Auto Immune Hemolytic Anemia None Blood and lymphatic system disorders None View
Infection None Infections and infestations None View
Graft Failure Post Transplant None Blood and lymphatic system disorders None View
Sepsis None Infections and infestations None View
Abdominal Pain None Gastrointestinal disorders None View
Nephrotic Syndrome None Renal and urinary disorders None View
VP Shunt Malfunction None Nervous system disorders None View
Multi System Organ Failure None General disorders None View
Seizure None Nervous system disorders None View
Respiratory Failure None Respiratory, thoracic and mediastinal disorders None View
Graft Versus Host Disease None General disorders None View
Central Line Removal None Surgical and medical procedures None View
Deep Vein Thrombosis None Blood and lymphatic system disorders None View
Hyperglycemia None Endocrine disorders None View
Pnematosis None Gastrointestinal disorders None View
Posterior Reversible Encephalopathy Syndrome None Nervous system disorders None View
Necrotic Ulcer (skin) None Skin and subcutaneous tissue disorders None View
Dental Rehabilitation None Surgical and medical procedures None View
Hemolytic Transfusion Reaction None Blood and lymphatic system disorders None View
GI Distress None Gastrointestinal disorders None View
Other Events(If Any):