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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT01704157
Description: None
Frequency Threshold: 3
Time Frame: Adverse events were collected from treatment day through Day 140
Study: NCT01704157
Study Brief: A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Treatment Cryo-Touch III Device 0 None 1 33 9 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Right leg numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seasonal Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arm Laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tenderness to palpation in thigh SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
clicking sound in knee with standing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tingling/pain in feet SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left Leg numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain/loss of full range of motion with pivot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea duringprocedure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View