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 |
|---|---|---|---|---|---|---|---|---|
| Insulin Lispro - Reference -15 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC 15 minutes prior to meal in one of six periods. | None | None | 0 | 30 | 0 | 30 | View |
| Insulin Lispro - Reference 0 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods. | None | None | 0 | 30 | 1 | 30 | View |
| LY900014 - Test -15 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC 15 minutes prior to meal in one of six periods. | None | None | 0 | 30 | 0 | 30 | View |
| LY900014 - Test 0 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods. | None | None | 0 | 30 | 0 | 30 | View |
| LY900014 - Test +15 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC 15 minutes after start of meal in one of six periods. | None | None | 0 | 30 | 1 | 30 | View |
| Insulin Lispro Open Label - (Part A) | Individualized doses of insulin lispro administered SC between periods. | None | None | 0 | 30 | 0 | 30 | View |
| LY900014 - Test (Part B) | Individualized doses of LY900014 (Test) administered SC immediately before meals for 14 days. | None | None | 0 | 15 | 1 | 15 | View |
| Insulin Lispro Open Label - (Part B) | Individualized doses of insulin lispro administered SC immediately before meals. | None | None | 0 | 30 | 0 | 30 | View |
| Insulin Lispro - Reference +15 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC 15 minutes after start of meal in one of six periods. | None | None | 0 | 30 | 0 | 30 | View |
| Insulin Lispro - Reference (Part B) | Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days. | None | None | 0 | 15 | 2 | 15 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |