Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-24 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT03074695
Description: None
Frequency Threshold: 0
Time Frame: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
Study: NCT03074695
Study Brief: DPE Technique in Labor Epidural for Morbidly Obese Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dural Puncture Epidural (DPE) Women who have analgesia initiated with a DPE technique Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL. 0 None 0 66 35 66 View
Standard Epidural (EPL) Women who have analgesia initiated with an epidural technique Standard Epidural (EPL): Standard epidural placement Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL. 0 None 0 66 32 66 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-dural Puncture Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fetal Bradycardia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View