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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT05405218
Description: AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
Frequency Threshold: 0
Time Frame: Adverse events were collected out to 1 year.
Study: NCT05405218
Study Brief: Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study. 0 None 1 94 1 94 View
Mini Open Carpal Tunnel Release (mOCTR) Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study. 0 None 0 28 1 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nerve Injury - Digital-Median SYSTEMATIC_ASSESSMENT Surgical and medical procedures Other View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nerve Injury - Digital-Median: Neurapraxia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Other View
Wound Dehiscence/ delayed healing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Other View