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 @ 4:47 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT05882318
Description: The analysis set is comprised of "treatment emergent" adverse events, defined as device- or procedure-related adverse events occurring on or after implantation or attempted implantation of eCoin. Safety results are summarized for all implanted patients. At each follow-up visit, adverse events were recorded on the CRF. Patients were unblinded following the 3 month visit and had the option to reprogram their devices. Results are reported based on the patient's original treatment arm.
Frequency Threshold: 0
Time Frame: 4 months post-activation
Study: NCT05882318
Study Brief: Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sensory eCoin Peripheral Neurostimulator System: The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management. 0 None 0 18 7 18 View
Subsensory eCoin Peripheral Neurostimulator System: The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management. 0 None 0 18 6 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Incision Site Impaired Healing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medical Device Site Erythema SYSTEMATIC_ASSESSMENT General disorders None View
Post Procedural Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Incision Site Discharge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Implant Site Oedema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision Site Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision Site Cellulitis, Medical Device Site Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Incision Site Pain, Implant Site Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Site Incision Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision Site Pain, Incision Site Hyperaesthesia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tendon Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Device Stimulation issue SYSTEMATIC_ASSESSMENT Product Issues None View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Implant Site Ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Implant Site Pain SYSTEMATIC_ASSESSMENT General disorders None View