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 |
|---|---|---|---|---|---|---|---|---|
| Study Arm | Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen. ViviGen Cellular Bone Matrix: Study participants will receive local autograft milled bone on one side of the fusion and an equal amount of Depuy Synthes ViviGen on the opposite side of the fusion | 0 | None | 6 | 21 | 14 | 21 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hip Arthroplasties | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alcohol Withdrawal | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shoulder Surgeries | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Altered Mental State | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Atrial Fibrillation (AFib) With Rapid Ventricular Response (RVR) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| subdural hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Worsened Back and/or Leg Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Epigastric or Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Increased Paresthesia or Weakness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Falls or injury | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Viral Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Shoulder Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| New Diagnosis of Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Adjacent Segment Disease | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |