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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT03835416
Description:
None
Frequency Threshold:
0
Time Frame:
From time of consent to completion of either 3 month or 6 month study, 4-7 months
Study:
NCT03835416
Study Brief:
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| WL-Control | 0.8 g protein per kg body weight. Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). | 0 | None | 0 | 32 | 10 | 32 | View |
| WL-Protein | \>30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance. Foods rich in high quality protein: Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description). | 1 | None | 1 | 32 | 13 | 32 | View |
| Consented, Not Randomized | Participants who consented but were never randomized due to participant withdrawal or not qualifying. | 0 | None | 0 | 41 | 2 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bladder tumor | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Surgery | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Broken bone | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Complications from Pulmonary Fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Frequent Urination | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory Illness | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dizziness, nausea, abdominal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shoulder pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Adrenal gland removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Shoulder surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Leg pain/weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Elevated blood pressure | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| ED visit for difficulty breathing/coughing blood possibly related to congestive heart failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shingles | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bursitis in elbow | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Blood clot in eye | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gluteal cleft abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |