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 (Part 1) | In a single 8-day period, participants received a single placebo oral dose after an overnight fast. | None | None | 0 | 19 | 4 | 19 | View |
| 1 mg LY2886721 (Part 1) | In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 8 | 2 | 8 | View |
| 7 mg LY2886721 (Part 1 - Fed and Fasted) | In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after breakfast (Fed). In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted). | None | None | 0 | 8 | 1 | 8 | View |
| 10 mg LY2886721 (Part 2) | Participants received a single 10-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 4 | 1 | 4 | View |
| 15 mg LY2886721 (Part 1) | In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 6 | 0 | 6 | View |
| 25 mg LY2886721 (Part 1) | In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 7 | 1 | 7 | View |
| 35 mg LY2886721 (Part 1) | In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 6 | 3 | 6 | View |
| 35 mg LY2886721 (Part 2) | Participants received a single 35-mg LY2886721 oral dose after an overnight fast. | None | None | 0 | 4 | 4 | 4 | View |
| Placebo (Part 2) | Participants received a single placebo oral dose after an overnight fast. | None | None | 0 | 4 | 3 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Vessel puncture site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Procedural headache | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| Procedural vomiting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |