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 |
|---|---|---|---|---|---|---|---|---|
| Core Stabilization Exercise | 7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles. | None | None | 0 | 19 | 0 | 19 | View |
| Conventional Treatment | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound. | None | None | 0 | 19 | 0 | 19 | View |