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: 2025-12-25 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT04070833
Description: Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; 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: Up to 111 weeks
Study: NCT04070833
Study Brief: Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vitamin D + Fish Oil Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]) 7 None 18 66 16 66 View
Vitamin D + Fish Oil Placebo Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo 4 None 20 75 16 75 View
Vitamin D Placebo + Fish Oil Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]) Vitamin D placebo: Vitamin D placebo 7 None 28 82 17 82 View
Vitamin D Placebo + Fish Oil Placebo Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo 4 None 19 67 15 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Malignant Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Major CVD SYSTEMATIC_ASSESSMENT Cardiac 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
Parathyroid condition SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney failure or dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stomach upset or pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bad taste in mouth SYSTEMATIC_ASSESSMENT General disorders None View
Increased burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View