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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:20 AM
NCT ID: NCT01694433
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT01694433
Study Brief: "Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Calcipotriene Cream The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Calcipotriene: 1g daily BID 0 None 0 33 18 33 View
Placebo The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Placebo: 1g daily BID 0 None 0 32 19 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bug bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bump on eyelid SYSTEMATIC_ASSESSMENT Eye disorders None View
Common cold/allergy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Facial dryness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Menstrual cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
GI Flu SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Facial irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View