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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
NCT ID:
NCT05200858
Description:
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
Frequency Threshold:
0
Time Frame:
AEs were collected from study start date (March 1 2022) to the study completion (December 1, 2023) in a non-systematic way. Per patient, AEs were collected up to 8 weeks after Baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence (assessed by monitoring device usage remotely) the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
Study:
NCT05200858
Study Brief:
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | 0 | None | 0 | 15 | 3 | 15 | View |
| Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. | 0 | None | 0 | 15 | 3 | 15 | View |
| Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | 0 | None | 0 | 12 | 0 | 12 | View |
| Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | 0 | None | 0 | 13 | 0 | 13 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Minor AE due to device misuse | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |