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 @ 5:18 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT04171050
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks postoperatively
Study: NCT04171050
Study Brief: Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Local Anesthesia Standard of care with local anesthesia used during surgery Local anaesthetic: Local anesthesia injections 0 None 0 22 6 22 View
Group 2: Local Anesthesia Plus Pudendal Nerve Block Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block 0 None 1 22 7 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospital readmission SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pudendal nerve entrapment SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary retention at 48hr SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Postoperative nausea SYSTEMATIC_ASSESSMENT General disorders None View
Anesthetic complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View