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 |
|---|---|---|---|---|---|---|---|---|
| Sitagliptin/Sitagliptin (Data Through Week 12) | The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12. | None | None | 3 | None | 21 | None | View |
| Placebo/Sitagliptin (Data Through Week 12) | The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12. | None | None | 1 | None | 23 | None | View |
| Pooled Sitagliptin (Data Through Week 52) | The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. | None | None | 7 | None | 80 | None | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Enteritis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Patella fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Pneumothorax traumatic | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Ligament injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Hepatic neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Coronary artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |