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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT01702805
Description: None
Frequency Threshold: 0.05
Time Frame: Birth to 37 weeks PMA
Study: NCT01702805
Study Brief: Transfusion of Prematures Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Tranfusion Threshold Transfusions were administered using a higher threshold hemoglobin value. AKA "Liberal Cell Transfusion" group. 146 None 206 908 184 908 View
Low Transfusion Threshold Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA "Restricted Red Cell Transfusion" group. 135 None 197 906 164 906 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Bell's stage > 2 Necrotizing Enterocolitis (NEC) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Esophageal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Spontaneous Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Severe Hemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Nosocomial Sepsis up to 24 hours post-transfusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Sepsis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Sepsis Fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Sepsis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Severe Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View
Persistent Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Pulmonary Air Leaks SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Pulmonary Hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Respiratory Deterioration up to 24 hours post-transfusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Severe Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 17.1 View
Ischemic Bowel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Respiratory Deterioration up to 24 hours post-transfusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View