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 |
|---|---|---|---|---|---|---|---|---|
| Intravenous Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. | 17 | None | 146 | 527 | 86 | 527 | View |
| Oral Antibiotics | Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics. Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines. | 6 | None | 138 | 527 | 80 | 527 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| All | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| C difficile | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Line complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Diabetic | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Neoplastic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Skin and soft tissue unrelated to original surgical site | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |