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 |
|---|---|---|---|---|---|---|---|---|
| Medical Care | Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants. Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient. | None | None | 0 | 84 | 18 | 84 | View |
| Group Exercise | Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function. Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers. | None | None | 0 | 72 | 25 | 72 | View |
| Manual Therapy and Exercise | This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include: Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor. | None | None | 0 | 84 | 54 | 84 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Joint soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |