Adverse Events Module

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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: 2025-12-24 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:11 PM
NCT ID: NCT01169259
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: NCT01169259
Study Brief: Vitamin D and Omega-3 Trial (VITAL)
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 Vitamin D3, one 2000 IU capsule/day 485 None 1673 12927 10086 12927 View
Vitamin D placebo Vitamin D placebo, one capsule/day 493 None 1659 12944 10098 12944 View
Active omega-3 fatty acids 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). 493 None 1613 12933 10094 12933 View
Omega-3 fatty acids placebo Omega-3 fatty acids placebo, one capsule/day 485 None 1619 12938 10090 12938 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
Placebo Vitamin D/Active Omega-3 fatty acids Vitamin D placebo, one 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). 252 None 822 6470 5037 6470 View
Placebo vitamin D/Placebo Omega-3 fatty acids Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day 241 None 837 6474 5101 6474 View
Active vitamin D/Placebo omega-3 fatty acids Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day 244 None 782 6464 5027 6464 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Invasive cancer of any type SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Major cardiovascular event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Death from cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer (in women) 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
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Parathyroid condition SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney failure or dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Easy bruising 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
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Frequent nosebleeds SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bad taste in mouth SYSTEMATIC_ASSESSMENT General disorders None View
Increased burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood in urine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View