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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:46 PM
NCT ID: NCT01696435
Description: Results for adverse events are reported by each of the 4 factorial arms of the trial.
Frequency Threshold: 0
Time Frame: Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Study: NCT01696435
Study Brief: VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
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 Placebo Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo: Fish oil placebo, one capsule per day 153 None 545 4573 2803 4573 View
Vitamin D Placebo + Fish Oil Vitamin D placebo: Vitamin D3 placebo, one capsule per day Fish oil: Omacor, one 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 \[DHA\]) 152 None 569 4563 2789 4563 View
Vitamin D + Fish Oil Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil: Omacor, one 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 \[DHA\]) 153 None 549 4608 2825 4608 View
Vitamin D Placebo + Fish Oil Placebo Vitamin D placebo: Vitamin D3 placebo, one capsule per day Fish oil placebo: Fish oil placebo, one capsule per day 133 None 570 4609 2876 4609 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Major cardiovascular event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Invasive cancer of any type SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastrointestinal Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperparathyroidism or parathyroid condition SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Easy bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Frequent nosebleeds SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Stomach upset or pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View