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: 2025-12-25 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT00412360
Description: Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Frequency Threshold: 0
Time Frame: 2 years post-transplant
Study: NCT00412360
Study Brief: Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single UCB Transplant Single Umbilical Cord Blood Unit Transplantation None None 5 112 0 112 View
Double UCB Transplant Double Umbilical Cord Blood Unit Transplantation None None 14 108 0 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemolytic anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (12.0) View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (12.0) View
Acute intracranial Hemorrage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Seizure/aspiration Pneumonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Pulmonary Hemorrage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Aspiration Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Other Events(If Any):