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 |
|---|---|---|---|---|---|---|---|---|
| Manual Therapy + Dry Needling | Manual therapy + Dry needling: 2 sessions, after a 7 days interval Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132) Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae | None | None | 0 | 47 | 0 | 47 | View |
| Manual Therapy + Sham Dry Needling | Manual therapy + Sham Dry needling: after a 7 days interval Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae | None | None | 0 | 54 | 0 | 54 | View |
| Untreated Control | Natural history of the condition | None | None | 0 | 30 | 0 | 30 | View |