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 |
|---|---|---|---|---|---|---|---|---|
| Reactive Care (RC) | Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Peer support: Access to educational and informational support by a trained peer coach | 0 | None | 0 | 141 | 0 | 141 | View |
| Proactive Care (PC) | Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates. Peer support: Access to educational and informational support by a trained peer coach Online platform: An online platform that provides educational, informational and access to several therapeutic device metrics Respiratory Therapist support: Limited medical support provided by trained Respiratory Therapists. | 0 | None | 0 | 153 | 0 | 153 | View |