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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT01688102
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01688102
Study Brief: The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Vitamin D3 Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \<35 ng/ml, subjects will receive additional doses of oral vitamin D. Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed None None 1 60 7 60 View
Ultraviolet Light Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \<35 ng/ml, subjects will receive additional doses of narrow band UVB. Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes None None 2 58 21 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound Infection None Infections and infestations None View
Hip Pain None Musculoskeletal and connective tissue disorders None View
Hypertension None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin erythema/burn None Skin and subcutaneous tissue disorders None View
GI Distress None Gastrointestinal disorders None View
Skin dryness/irritation None Skin and subcutaneous tissue disorders None View
Constipation/Hemmorhoids None Gastrointestinal disorders None View
Tooth infection None Infections and infestations None View