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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
NCT ID:
NCT02646618
Description:
None
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT02646618
Study Brief:
Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Get Social | Get Social participants will receive a weight loss intervention in a "protected" Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. Get Social: Online-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants | 0 | None | 0 | 167 | 52 | 167 | View |
| Traditional | Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. Traditional: Group-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants | 0 | None | 0 | 162 | 49 | 162 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Musculoskeletal Pain or Injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Communicable Disease (Cold, Flu, Pneumonia) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Procedure/Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Cardiac Issue | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal Issue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diabetes or Blood Glucose Issue | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Changed Dose of Antidepressant Medication | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cancer | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gyno/Urological Issue | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Non-musculoskeletal injury, result of accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Depression/Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Nerve Condition or Swelling in Legs | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Eye/Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Autoimmune Disease | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Asthma Exacerbation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fatty Liver Disease | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bariatric Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Lyme Disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sleep Apnea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |