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 |
|---|---|---|---|---|---|---|---|---|
| Preterm Labor | Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term . immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department. | None | None | 0 | 30 | 0 | 30 | View |
| Term Labor | Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy . immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department. | None | None | 0 | 30 | 0 | 30 | View |