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 @ 7:22 PM
Ignite Modification Date: 2025-12-25 @ 5:01 PM
NCT ID: NCT04428203
Description: Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Frequency Threshold: 0
Time Frame: 120 days
Study: NCT04428203
Study Brief: Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Dose Escalation: Epidiolex 600 mg Cohort 1 participants with rising PSA after failure of localized therapy will receive 600 mg oral solution Epidiolex once daily for a total of 90 days in the absence of disease progression or unacceptable toxicity followed by a 10-day taper with 30 days of follow up after the discontinuation (last dose) of Epidiolex 1 None 0 2 2 2 View
Experimental: Dose Escalation and Expansion: Epidiolex 800 mg Both Escalation and Expansion Cohorts participants with rising PSA after failure of localized therapy will receive the MTD of 800 mg oral solution Epidiolex once daily for a total of 90 days in the absence of disease progression or unacceptable toxicity followed by a 10-day taper with 30 days of follow up after the discontinuation (last dose) of Epidiolexdose 0 None 0 17 9 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal Liver Function Test SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View