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: 2025-12-24 @ 9:06 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT02314104
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02314104
Study Brief: Efficacy of Transversus Abdominis Plane Block Versus Local Injection of Pain Medication
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment TAP, Placebo Local Injection Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. None None 0 71 0 71 View
Placebo TAP, Treatment Local Injection Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. None None 0 78 0 78 View
Treatment TAP, Treatment Local Injection Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. None None 0 71 0 71 View
Serious Events(If Any):
Other Events(If Any):