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 |
|---|---|---|---|---|---|---|---|---|
| Ondansetron - Mothers | Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery; may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. | 0 | None | 1 | 48 | 1 | 48 | View |
| Ondansetron - Neonates | Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days). | 0 | None | 2 | 48 | 18 | 48 | View |
| Placebo - Mothers | Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group); may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. | 0 | None | 1 | 50 | 1 | 50 | View |
| Placebo - Neonates | Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV). | 0 | None | 4 | 50 | 15 | 50 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| C-section superficial wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intermittent seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Late onset NOWS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Readmission for NOWS observation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hypoxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Subcutaneous hematoma drainage from C-section incision | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Vaginal bleeding | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Prolonged QTc interval | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Short QTc interval | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cyanotic episode | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Laryngomalacia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Left brachial plexus injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Secundum atrial septal defect | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |