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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
NCT ID:
NCT00607893
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00607893
Study Brief:
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment CPAP | Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device. Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks. | 0 | None | 3 | 76 | 32 | 76 | View |
| SHAM CPAP | Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device. Sham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks. | 0 | None | 3 | 77 | 27 | 77 | View |
| Run-in/Washout Treatment CPAP | The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP. | 0 | None | 6 | 153 | 23 | 153 | View |
| Run-in/Washout Sham CPAP | The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure). | 0 | None | 2 | 153 | 8 | 153 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest Pain (went to ER) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Enlarged coronary artieries/chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Irregular heartbeat (went to ER) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| New onset atrial flutter (shown on psg) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| ER with swollen Knee (hospitalized) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalized for seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dehydration and possible kidney failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Asthma exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonia/Influenza | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Spot on lung - biopsy for cancer | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Foot ulcer amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ruptured appendix | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bruise from venipucture | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nose bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Elevated glucose level | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Chronic pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Developed sciatica | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Fell and bruised rib | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| General pain (leg, back, muscle) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hand injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Knee replacement | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| auto accident / physical therapy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Breathing problems | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cold/congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dry cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Non-productive cough/post nasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sinus infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Spot on lung (possible cancer) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Strep throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Abrasion on bridge of nose from CPAP mask | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Cysts on chin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Flare up of eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Redness on external nares from nasal pillow mask marks on face from maks | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tumor removed from finger | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ulcer on foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| scabs on head from electrodes from psg | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Kidney Stone | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Tooth extracted/root canal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Elevated blood pressure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart monitor for irregular heartbeat | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Run of nonsustained ventricular tachycardia on PSG | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Cataract surgery | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye infection/injury | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Abdominal cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |