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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Noom Health | In Noom Health, participants encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss. | 0 | None | 1 | 302 | 43 | 302 | View |
| Noom Digital Health | In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content. | 0 | None | 2 | 298 | 42 | 298 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis - unrelated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Food poisoning - unrelated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomach cramps - unrelated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Allergic reaction - unrelated | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dental problem - unrelated | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unknown health problem - unrelated | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Viral/bacterial Illness - unrelated | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Car accident - unrelated | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Injury - unrelated | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Fibromyalgia - unrelated | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Multiple Sclerosis - unrelated | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain/muscular issue - unrelated | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cancer - unrelated | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breastfeeding - unrelated | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Pregnancy - unrelated | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Anxiety - unrelated | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depression - unrelated | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Swelling - unrelated | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Surgery - unrelated | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Migraine - unrelated | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |