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 |
|---|---|---|---|---|---|---|---|---|
| Saline Irrigation | Normal saline is to be placed into the dissected retromuscular space AFTER placement and fixation of mesh. This should fill the cavity completely to the level of the skin. Irrigant is to be left to stand for a total of three minutes and then evacuated. Additional irrigation with saline PRIOR to the randomization is permitted at the surgeons' discretion for hemostasis with no requirement for duration. Additional saline irrigation of the subcutaneous space after fascia closure should be performed prior to skin closure. Normal saline: Comparison of saline solution rinse vs antibiotic rinse | 1 | None | 9 | 124 | 13 | 124 | View |
| Antibiotic Irrigation | Antibiotic solution is prepared consisting of 240 mg gentamicin and 600 mg clindamycin in 500 ml saline to ensure proper concentration. This solution should be placed into the dissected retromuscular space AFTER placement and fixation of mesh. This should fill the cavity completely to the level of the skin. Irrigant is to be left to stand for a total of three minutes and then evacuated. Additional irrigation with saline PRIOR to the randomization is permitted at the surgeons' discretion for hemostasis with no requirement for duration. Additional antibiotic irrigation of the subcutaneous space after fascia closure should be performed prior to skin closure. This second irrigation is not timed. Gemcitabine/ clindamycin: Comparison of saline solution rinse vs antibiotic rinse | 3 | None | 5 | 126 | 7 | 126 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| bowel obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| hematoma | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| respiratory insufficiency | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| alcohol withdrawal | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| lethargy | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |