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 |
|---|---|---|---|---|---|---|---|---|
| Physiotherapist as Primary Assessor | The healthcare process started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients could seek a physician anytime after the first assessment with the physiotherapist. Physiotherapist as primary assessor: Physiotherapist diagnosed and treated the patient. | 0 | None | 0 | 35 | 0 | 35 | View |
| Physician as Primary Assessor | The healthcare process started with a physician assessment and treatment. Treatments could involve drug prescriptions, referral to x-ray, referrals to other healthcare providers and sick-leave. Patients could seek a physiotherapist anytime after the first assessment with the physician. Physician as primary assessor: Physician diagnosed and treated the patient. | 0 | None | 0 | 34 | 0 | 34 | View |