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 |
|---|---|---|---|---|---|---|---|---|
| Aerobic Exercise | Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011). | None | None | 0 | 16 | 0 | 16 | View |
| Video Game | The game "Reflex Ridge" of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA). | None | None | 0 | 20 | 0 | 20 | View |