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 @ 2:29 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
NCT ID:
NCT01152359
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01152359
Study Brief:
Considering Patient Diet Preferences to Optimize Weight Loss
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Choice Arm | Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity. | None | None | 4 | 105 | 17 | 105 | View |
| Control Arm | Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity. | None | None | 4 | 102 | 10 | 102 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CHF | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| hip surgery | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| spine surgery | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| gallbladder surgery | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| finger infection | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| snake bite | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Elevated blood pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| broken hand | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| lumps in hand | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| angioedema | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| inner ear infection | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| hypoglcyemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| kidney stone | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| sciatica | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| motor vehicle collision | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| heartburn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dysphonia/vocal cord disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |