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 |
|---|---|---|---|---|---|---|---|---|
| Comprehensive Care | Comprehensive care Comprehensive care programme: Intervention group: * Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions * Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation) * Respiratory physician assessment and optimization of treatment * Patients will also be taught about a personalized action plan by the physician and respiratory nurse. * Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries. | None | None | 0 | 90 | 0 | 90 | View |
| Control Group | Control arm with usual care | None | None | 0 | 90 | 0 | 90 | View |