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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT02468934
Description: None
Frequency Threshold: 0
Time Frame: 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
Study: NCT02468934
Study Brief: Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enrolled/Received Leads This group includes subjects that were consented, met eligibility criteria, and received Leads. 0 None 1 24 18 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/Upset Stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation SYSTEMATIC_ASSESSMENT General disorders None View
Common Cold SYSTEMATIC_ASSESSMENT General disorders None View
Small dehiscence at Total Knee Arthroplasty (TKA) surgical site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Iliotibial Band Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pulled Hamstring SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Pain/Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased Pain (Hip and Leg) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain due to Stimulation SYSTEMATIC_ASSESSMENT Product Issues None View
Shocks at Lead Exit Site SYSTEMATIC_ASSESSMENT Product Issues None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin irritation or bruising at Lead exit site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation/dermatitis from bandages SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation from SPRINT Pad SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-specified skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Affected Leg Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Knee Stiffness/Decreased Range of Motion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View