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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT04486560
Description: Primary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade ≥ 3, pneumothorax grade ≥ 2, post-procedure respiratory failure, and/or death related to the device. Secondary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade \< 3 and/or pneumothorax grade \< 2 related to the device.
Frequency Threshold: 0
Time Frame: Day of procedure through 30 days post-procedure
Study: NCT04486560
Study Brief: Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm: Cryoprobe Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath 0 None 0 50 22 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
SECONDARY SAFETY ENDPOINT Adverse Event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View