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 |
|---|---|---|---|---|---|---|---|---|
| Esl 800 mg | Eslicarbazepine Acetate (Esl) tablets (800 mg) QD | None | None | 11 | 72 | 43 | 72 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Glioblastoma multiforme | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Postictal psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Upper airway obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |