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 and Microginon® | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period | None | None | 0 | 20 | 18 | 20 | View |
| Microginon® | A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel) | None | None | 0 | 20 | 8 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Xerophthalmia | None | Eye disorders | MedDRA (12.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Dry throat | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Hypoaesthesia oral | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Paraesthesia oral | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Toothache | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vessel puncture site haematoma | None | General disorders | MedDRA (12.0) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (12.0) | View |
| Heat stroke | None | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (12.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Joint range of motion decreased | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Diplopia | None | Nervous system disorders | MedDRA (12.0) | View |
| Dizziness | None | Nervous system disorders | MedDRA (12.0) | View |
| Headache | None | Nervous system disorders | MedDRA (12.0) | View |
| Somnolence | None | Nervous system disorders | MedDRA (12.0) | View |
| Syncope | None | Nervous system disorders | MedDRA (12.0) | View |
| Tremor | None | Nervous system disorders | MedDRA (12.0) | View |
| Anxiety | None | Psychiatric disorders | MedDRA (12.0) | View |
| Libido increased | None | Psychiatric disorders | MedDRA (12.0) | View |
| Dysuria | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Metrorrhagia | None | Reproductive system and breast disorders | MedDRA (12.0) | View |
| Asthmatic crisis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Throat irritation | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Cheilitis | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Rash macular | None | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Sexual activity increased | None | Social circumstances | MedDRA (12.0) | View |