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 @ 5:46 PM
Ignite Modification Date:
2025-12-25 @ 3:13 PM
NCT ID:
NCT00967668
Description:
For every category, events are based on what patients self-reported to a study team member. ASPIRE participants had more opportunities to report events because of interactions with their coach in addition to assessments. MOVE! participants only reported at assessments.
Frequency Threshold:
0
Time Frame:
Adverse events are reported for the full 2-years of participation of each individual.
Study:
NCT00967668
Study Brief:
Coaching Veterans to Healthy Weights and Wellness
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ASPIRE-Phone Lifestyle Coaching | Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA) Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle. | None | None | 0 | 162 | 45 | 162 | View |
| ASPIRE-Group Lifestyle Coaching | On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA) Small change approach to improving physical activity and diet: The "Aspire to Lifelong Health" (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle. | None | None | 0 | 160 | 33 | 160 | View |
| MOVE! Usual Care | Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care. | None | None | 0 | 159 | 15 | 159 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| stomach problems | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| multiple systems or other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| rashes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| low pulse, chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| blood sugar | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| sore muscles and joints | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| minor injuries while exercising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| sinus, breathing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |