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 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
NCT ID:
NCT01351805
Description:
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleeding, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash
Omega-3 FA Monitored safety cond'ns: GI bleeding; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
Frequency Threshold:
0
Time Frame:
5 years
Study:
NCT01351805
Study Brief:
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Active Vitamin D/ Active Omega-3 Fatty Acids | Vitamin D3, one 2000 IU capsule/day Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA). | 241 | None | 791 | 6463 | 5101 | 6463 | View |
| Active Vitamin D/ Active Omega-3 Placebo | Vitamin D3, one 2000 IU capsule/day Omega-3 fatty acids placebo, one capsule/day | 244 | None | 782 | 6464 | 5027 | 6464 | View |
| Active Omega-3 Fatty Acids, Placebo Vitamin D | Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA). Vitamin D placebo, one capsule/day | 252 | None | 822 | 6470 | 5037 | 6470 | View |
| Omega-3 Fatty Acids Placebo/ Placebo Vitamin D | Omega-3 fatty acids placebo, one capsule/day Vitamin D placebo, one capsule/day | 241 | None | 837 | 6474 | 5101 | 6474 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Invasive cancer of any type | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Death from cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Prostate cancer (in men) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Colorectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Death from cardiovascular causes | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Breast cancer (in women) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Major cardiovascular event | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Easy bruising | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Frequent nosebleeds | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood in urine | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Stomach upset or pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Increased burping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Kidney stones | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Kidney failure or dialysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Parathyroid condition | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bad taste in mouth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |