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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT02237092
Description: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
Frequency Threshold: 0
Time Frame: During the operation, an average of 30 minutes
Study: NCT02237092
Study Brief: Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Level of Sensory Block => Th4 (Spinal Anesthesia) Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure None None 23 62 0 62 View
Level of Sensory Block < = Th5 (Spinal Anesthesia) Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure None None 17 134 0 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders Hypotension View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Changing the type of anesthesia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions General anesthesia View