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 |
|---|---|---|---|---|---|---|---|---|
| Standard of Care-Treated Wounds (Randomized Period) | Adverse events localized to the area of the body with wounds that were randomized to receive standard of care treatment. | 0 | None | 0 | 6 | 3 | 6 | View |
| Matrix-Treated Wounds (Open-Label Period) | Adverse events localized to the area of the body with wounds that were selected to receive matrix application, no randomization, no controls. | 0 | None | 0 | 1 | 0 | 1 | View |
| Systemic Adverse Events (Randomized Period) | All Adverse Events, including those that affected participants as a whole (systemic events) | 0 | None | 1 | 6 | 5 | 6 | View |
| Systemic Adverse Events (Open-Label Period) | All Adverse Events, including those that affected participants as a whole (systemic events) | 0 | None | 0 | 1 | 1 | 1 | View |
| Matrix-Treated Wounds (Randomized Period) | Adverse events localized to the area of the body with wounds that were randomized to receive matrix application. | 0 | None | 0 | 6 | 3 | 6 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (v5.0) | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (v5.0) | View |
| Lymph node infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (v5.0) | View |
| Headache, migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (v5.0) | View |
| Pruritis, requiring treatment | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | View |
| Pain of skin, requiring treatment | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | View |
| Bacterial colonization | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (v5.0) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (v5.0) | View |
| Toothache, chipped tooth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (v5.0) | View |
| Allergic reaction, seasonal allergies | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (v5.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (v5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (v5.0) | View |
| Premature menopause | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (v5.0) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (v5.0) | View |
| Bullous dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | View |
| Vision decreased, hyperopia | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (v5.0) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (v5.0) | View |