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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| The Acupuncture Group | Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), and Shenmen(HT7) for upper limbs. For palm numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), and Zusanli(ST36) for lower limbs. For the acupuncture points, Taixi(KI3) and Yongquan(K1) should be added for foot numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints . acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints | 0 | None | 0 | 10 | 0 | 10 | View |
| The Controlled Group | Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation. acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints | 0 | None | 0 | 10 | 0 | 10 | View |