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 |
|---|---|---|---|---|---|---|---|---|
| SI+CC | Chest compression will be superimposed by sustained inflations during CPR: "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC. CC+SI: Chest compression will be superimposed by sustained inflation during CPR | 2 | None | 1 | 5 | 0 | 5 | View |
| 3:1 CPR | CPR using 3:1 C:V ratio: "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC. 3:1 CPR: CPR using 3:1 ratio (control group) | 0 | None | 4 | 4 | 0 | 4 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Air leak | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Intraventricular haemorrhage all grades | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Intraventricular haemorrhage grade >3 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |