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 |
|---|---|---|---|---|---|---|---|---|
| Phenobarbital | Phenobarbital, 4-5 mg/kg/day, for 4 months phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months | None | None | 1 | 8 | 6 | 8 | View |
| Placebo | Placebo in a volume equivalent to active drug for 4 months placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months | None | None | 1 | 5 | 5 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | None | General disorders | None | View |
| Haematochezia | None | Gastrointestinal disorders | None | View |
| sinusitis | None | Infections and infestations | None | View |
| apnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| convulsion | None | Nervous system disorders | None | View |
| upper respiratory tract infection | None | Infections and infestations | None | View |
| seborrhoeic dermatitis | None | Skin and subcutaneous tissue disorders | None | View |
| flatulence | None | Gastrointestinal disorders | None | View |
| nasal congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| rash | None | Skin and subcutaneous tissue disorders | None | View |
| status epilepticus | None | Nervous system disorders | None | View |
| poor quality sleep | None | Nervous system disorders | None | View |
| influenza | None | Infections and infestations | None | View |
| ear infection | None | Ear and labyrinth disorders | None | View |
| gastrooesophageal reflux disease | None | Gastrointestinal disorders | None | View |
| otitis media | None | Ear and labyrinth disorders | None | View |
| vomiting | None | Gastrointestinal disorders | None | View |
| Croup infection | None | Infections and infestations | None | View |
| Candidiasis | None | Infections and infestations | None | View |
| Rhinovirus infection | None | Infections and infestations | None | View |
| Respiratory Syncytial Virus infection | None | Infections and infestations | None | View |