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
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
NCT ID:
NCT01312233
Description:
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
Frequency Threshold:
0
Time Frame:
3 months
Study:
NCT01312233
Study Brief:
Collaborative Care for Older Adults With Back Pain (COCOA)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dual Care | Unlinked co-occurrence of conventional medical care and chiropractic care Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. | 0 | None | 0 | 44 | 36 | 44 | View |
| Shared Care | Co-management of medical care and chiropractic care Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care. | 0 | None | 0 | 44 | 34 | 44 | View |
| Medical Care | Conventional medical care alone Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. | 0 | None | 0 | 43 | 10 | 43 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Spine-related pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spine-related pain with radiation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Extremity pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| General stiffness/tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasm/cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Numbness/tingling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| General soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tiredness/fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness/imbalance/vertigo | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lower respiratory infection | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sinus congestion/respiratory symptoms/allergy | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Migraine | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Laceration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| General soreness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chipped tooth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Allergic rash | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cold sore | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin burning sensation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| GERD | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin allergic reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Concussion | SYSTEMATIC_ASSESSMENT | General disorders | None | View |