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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT03066193
Description: None
Frequency Threshold: 0
Time Frame: Collected at each study visit. Participants would come in every two weeks for twelve weeks.
Study: NCT03066193
Study Brief: Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette 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
Dronabinol and Palmitoylethanolamide All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol. Dronabinol and Palmitoylethanolamide: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks. 0 None 0 16 16 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue/Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Feeling "high" SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Dry Mouth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders AERS View
Dizziness/Lightneadedness SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Difficulty concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Weakness, unsteadiness SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Warmth or tingly feeling SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Gaps in memory SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Clumsiness SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Lack of coordination SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Depersonalization SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Increased apetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders AERS View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders AERS View
Exagerated sense or well being SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Red eyes SYSTEMATIC_ASSESSMENT Eye disorders AERS View
Heavy limbs/muscles SYSTEMATIC_ASSESSMENT Nervous system disorders AERS View
Sleep problems (insomnia) SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders AERS View
Decrease in apetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders AERS View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Mood changes SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Muscle aches/pains SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders AERS View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders AERS View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders AERS View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders AERS View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders AERS View