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 |
|---|---|---|---|---|---|---|---|---|
| Shared Decision Making | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. | 1 | None | 49 | 114 | 0 | 114 | View |
| Usual Care | Physician Usual Care of depressed patients. Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. | 0 | None | 47 | 88 | 0 | 88 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ER visit | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hospitalization | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| hospitalization | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| hospitalization | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| ambulatory surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |