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 |
|---|---|---|---|---|---|---|---|---|
| REACH Participant Course | This study will run twice a week over 8 weeks with 6 REACH sessions 8 optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study. REACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC. | 0 | None | 0 | 11 | 0 | 11 | View |