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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | 0 | None | 2 | 2 | 1 | 2 | View |
| Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | 0 | None | 0 | 1 | 1 | 1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 27.0 | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Rhinovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | View |