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 |
|---|---|---|---|---|---|---|---|---|
| Trial Of Labour After Caesarean Section | The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis: -Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy -Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any -Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence) -Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality | None | None | 0 | 368 | 0 | 368 | View |