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 |
|---|---|---|---|---|---|---|---|---|
| Immediate Corrective Exercises | After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: 1. Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. 2. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. 3. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. | 0 | None | 0 | 21 | 0 | 21 | View |
| Immediate Use of Pelvic Support Belt | Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. | 0 | None | 0 | 21 | 6 | 21 | View |
| Delayed Treatment | These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention. | 0 | None | 0 | 20 | 0 | 20 | View |