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 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
NCT ID:
NCT03104192
Description:
None
Frequency Threshold:
5
Time Frame:
3 months
Study:
NCT03104192
Study Brief:
MOWI Research Pilot
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology. Develop \& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks. | 0 | None | 1 | 9 | 4 | 9 | View |
| MOWI Weight Loss Maintenance | Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI. MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification). | 0 | None | 0 | 23 | 0 | 23 | View |
| Develop & Refine MOWI w Fitbit (2B) | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology. Develop \& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. | 0 | None | 3 | 14 | 12 | 14 | View |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein. Develop \& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions. | 0 | None | 1 | 14 | 5 | 14 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constitutional | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |