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 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
NCT ID:
NCT02047032
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT02047032
Study Brief:
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Electroacupuncture | BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks). acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand. | None | None | 0 | 250 | 41 | 250 | View |
| Solifenacin Plus PFMT | Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks. solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 ) PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE). | None | None | 1 | 250 | 90 | 250 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| blurred vision | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| hypogeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| low back pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| pruritus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dysuria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| facial edema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| subcutaneous hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| stomach | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| heartburn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |