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 |
|---|---|---|---|---|---|---|---|---|
| Rivastigmine 5 and 10 cm^2 Patch | For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability. | None | None | 18 | 208 | 49 | 208 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 12.1 | View |
| Blood glucose abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 12.1 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 12.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 12.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 12.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 12.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 12.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 12.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 12.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 12.1 | View |
| Brain neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Dysstasis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 12.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 12.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 12.1 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 12.1 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 12.1 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | 12.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 12.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 12.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 12.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 12.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 12.1 | View |