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 |
|---|---|---|---|---|---|---|---|---|
| Standard Rapamycin Dose (STD) | Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml | None | None | 2 | 10 | 10 | 10 | View |
| Low Dose Rapamycin (LD) | Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml | None | None | 1 | 10 | 6 | 10 | View |
| Standard Care | Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension | None | None | 1 | 10 | 8 | 10 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pulmonary embolus | None | Respiratory, thoracic and mediastinal disorders | None | View |
| nephrotic range proteinuria | None | Renal and urinary disorders | None | View |
| Decrease visual acuity | None | Eye disorders | None | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral ulcerations | None | Immune system disorders | None | View |
| Nonserious infections | None | Infections and infestations | None | View |
| Edema | None | Blood and lymphatic system disorders | None | View |
| Gastrointestinal symptoms | None | Gastrointestinal disorders | None | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | None | View |
| Miscellaneous/other | None | General disorders | None | View |