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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Following the body weight, patients will be allocated to one of the following regimen: Placebo Patients \< 45 kg - 3 tablets 3 times a day with meals Placebo Patients \> 45 kg - 5 tablets 3 times a day with meals Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals). | None | None | 0 | 13 | 9 | 13 | View |
| Idebenone | Following the body weight, patients will be allocated to one of the following regimen: Idebenone Patients \< 45 kg - 3 tablets 3 times a day with meals Idebenone Patients \> 45 kg - 5 tablets 3 times a day with meals Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals). | None | None | 1 | 16 | 12 | 16 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fall | None | Injury, poisoning and procedural complications | None | View |
| Fatigue | None | General disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Speech disorder | None | Nervous system disorders | None | View |
| Pain | None | General disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Parathyroid gland enlargement | None | Endocrine disorders | None | View |
| Gastrointestinal disorder | None | Gastrointestinal disorders | None | View |