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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT04527003
Description: At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT04527003
Study Brief: Cannabidiol and Management of Endometriosis Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group C - High Dose CBD Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily) Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system. Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation. 0 None 0 3 0 3 View
Group A - Placebo Norethindrone acetate (5mg daily) + Placebo Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation. Placebo: a substance or treatment which is designed to have no therapeutic value 0 None 0 4 3 4 View
Group B - Low Dose CBD Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily) Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system. Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gagging (when taking study drug) SYSTEMATIC_ASSESSMENT General disorders None View
Night sweats SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ulcer on lip SYSTEMATIC_ASSESSMENT General disorders None View