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 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
NCT ID:
NCT00578734
Description:
None
Frequency Threshold:
5
Time Frame:
14 days from randomization or until resolution of adverse events.
Study:
NCT00578734
Study Brief:
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Event Groups(If Any):
Event Groups
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Apnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Endotracheal intubation complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Coarctation of the aorta | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (10.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Hepatitis cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Neurological symptom | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Chylothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pertussis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Drug withdrawal syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Metabolic alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Stridor | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Dermatitis diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |