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 @ 1:55 PM
Ignite Modification Date:
2025-12-25 @ 12:44 PM
NCT ID:
NCT02428595
Description:
No difference in definitions. Adverse Event Categories: The majority of specific adverse events in this study occurred with very low frequency, which would not exceed common reporting thresholds. In order to provide a more accurate impression of the patient risk and to be more conservative in reporting, these low frequency events were gathered into groups by their systemic impact.
Frequency Threshold:
0
Time Frame:
Events were collected for the full duration of study, including the fitting and treatment periods, for a total participation of 3.5-15 months (typically 13 months). For further detail, the fitting period, which occurs first, requires 2-4 weeks, but can be repeated up to 3 times, for a total of 2-12 weeks in this phase (typically 4 weeks). The treatment period, which follows the fitting period, is a minimum of 3 months and up to 12 months (typically 12 months).
Study:
NCT02428595
Study Brief:
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fitting | All subjects who underwent the fitting process (interacted with a device), including those who did not enter the treatment period. The fitting process involved an office visit with a pelvic exam, followed by test fittings of the device to determine the correct size. Patients who were successfully fit then took home the Trial Insert device and wore it during the 2 weeks during which they collected diary data (logging bowel movements and incontinence episodes). This trial wear period was allowed to be extended due to scheduling or if the patient chose not to use the device during their menstrual cycle. Patients who did not achieve a successful fit were allowed to change device size and repeat the trial period up to 2 additional times (for a total of 3 fitting cycles). | 0 | None | 0 | 137 | 62 | 137 | View |
| Treatment | All subjects who were successfully fit and completed their eligibility diary and who entered the 12 month treatment period. This includes patients who did not complete treatment. In treatment, subjects wore the Eclipse Insert and inflated it 3x per day using the provided Pump. Patients could remove and reinsert the device as needed for cleaning or pelvic rest. | 0 | None | 8 | 73 | 28 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Suicidal ideations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Acute stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Worsening degenerative joint disease | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vaginal Mucosal Wall Injury | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Lower Urinary Tract Issues | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal/Pelvic Discomfort/Irritation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal Infections | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |