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 |
|---|---|---|---|---|---|---|---|---|
| Topiramate Monotherapy | Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8. | None | None | 1 | 35 | 33 | 35 | View |
| Topiramate add-on Therapy | Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8. | None | None | 1 | 20 | 20 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Hypoaesthesia facial | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |