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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT02504151
Description: AEs were collected by randomization arm, not by intervention method (order in the crossover).
Frequency Threshold: 5
Time Frame: Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
Study: NCT02504151
Study Brief: Cannabidiol Treatment in Patients With Early Psychosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cannabidiol, Then Placebo The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo. Period 1: CBD, 800 mg/day Period 2: Placebo 0 None 2 8 5 8 View
Placebo, Then Cannabidiol The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day). Period 1: Placebo Period 2: CBD, 800 mg/day 0 None 0 10 6 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Depressed mood, racing thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ER Visit SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Tension headache SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT General disorders None View
Sedation SYSTEMATIC_ASSESSMENT General disorders None View
Scratchy throat and cold symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Stye in left eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Right shin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased itchiness of rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased tiredness SYSTEMATIC_ASSESSMENT General disorders None View
Veisalgia SYSTEMATIC_ASSESSMENT General disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High blood pressure/hospitalization SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Relapse to PCP, LSD, and opiate use SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash around tattoo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleeplessness SYSTEMATIC_ASSESSMENT General disorders None View
Pulled leg muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tingling and numbness on right side to body and face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Contact dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in right forearm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Swollen left foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening of symptoms and more negative affect SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flu SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT General disorders None View