Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT01868633
Description: None
Frequency Threshold: 0
Time Frame: A safety analysis of adverse events was done by a clinician investigator not involved in study after enrollment of every 20 patients and at the 6th-week postnatal outpatient visit( That is 6 weeks after exposure to the intervention). Adverse event data collected included surgical wound examination findings (signs of infection, poor healing, wound breakdown), postpartum blood loss and vital signs ( blood pressure, heart rate and temperature)
Study: NCT01868633
Study Brief: Dexamethasone for Post Cesarean Delivery Analgesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dexamethasone & Spinal Morphine intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively Dexamethasone None None 0 26 0 26 View
Placebo Injection and Spinal Morphine intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively Placebo None None 0 26 0 26 View
Serious Events(If Any):
Other Events(If Any):