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 @ 10:53 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT02948569
Description: The following adverse events were queried at screening and during the 6 study visits over 20 days. 1. Disturbed bowel habits 2. Constipation 3. Diarrhea 4. Dry mouth 5. Dry skin 6. Fatigue 7. Flatulence 8. Hair loss 9. Headache 10. Itching 11. Loss of appetite 12. Nausea and vomiting 13. Sleep disturbances 14. Tiredness
Frequency Threshold: 0
Time Frame: 20 days
Study: NCT02948569
Study Brief: Evaluation of 3-V Bioscience-2640 to Reduce de Novo Lipogenesis in Subjects With Characteristics of Metabolic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3-V Bioscience-2640 Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-26400 before bedtime or 22:30, whichever comes first, for 10 days. 0 None 0 12 2 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View