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 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
NCT ID:
NCT01726504
Description:
All Adverse events（AE）were recorded and measured by both participants themselves and acupuncturists.3 cases(2 in electro-acupuncture(EA)group and 1 in sham EA group)dropped out of this research before getting any intervention for effect,only having baseline data.Multipl imputation was adopted for these 3 in outcome measure part,but not for AE part.
Frequency Threshold:
0
Time Frame:
All through the study
Study:
NCT01726504
Study Brief:
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Electro-acupuncture | Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi. | None | None | 0 | 534 | 31 | 534 | View |
| Sham Electro-acupuncture | Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation. | None | None | 0 | 538 | 24 | 538 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Left needle | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nausea during acupuncture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Faint during acupuncture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Unbearable pricking (VAS≥8) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pricking lasted more than 0.5 hour | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hematoma around the site of needling | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bleeding/numbness/infection around the site of needling | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Sleeplessness after acupuncture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dizziness after acupuncture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Other discomforts after acupuncture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |