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 |
|---|---|---|---|---|---|---|---|---|
| TBI-ACUP | This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. | 0 | None | 0 | 5 | 0 | 5 | View |
| TBI-SHAM | This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin. | 0 | None | 0 | 4 | 0 | 4 | View |
| C-ACUP | This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. | 0 | None | 0 | 4 | 0 | 4 | View |
| C-SHAM | This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin. | 0 | None | 0 | 4 | 0 | 4 | View |
| C-EX | This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. | 0 | None | 0 | 4 | 0 | 4 | View |