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
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
NCT ID:
NCT03824769
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
Study:
NCT03824769
Study Brief:
Physical Activity Choices Everyday
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. | 0 | None | 0 | 24 | 9 | 24 | View |
| Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking | Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. | 0 | None | 0 | 28 | 7 | 28 | View |
| Phase I Only (Weight Loss Phase): 16 Weeks | This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase). | 0 | None | 2 | 108 | 4 | 108 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscle or bone injury (e.g., broken bone, torn ligament, sprain) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gall bladder attack or surgery | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| New diagnosis, started treatment, or hospitalized for depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Stroke, ministroke (TIA), or other neurological problems | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |