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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT00745420
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: 2
Time Frame: 2 years post-transplant
Study: NCT00745420
Study Brief: Evaluating the Safety and Effectiveness of Bone Marrow Transplants in Children With Sickle Cell Disease (BMT CTN 0601)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hematopoietic Stem Cell Transplantation Bone Marrow Transplant with GVHD Prophylaxis Regimen None None 21 29 2 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Autoimmune haemolytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (12.0) View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Oxygen saturation decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (12.0) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Posterior reversible encephalopathy syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (12.0) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.0) View
Cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View