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: 2025-12-26 @ 10:36 AM
Ignite Modification Date: 2025-12-26 @ 10:36 AM
NCT ID: NCT02006628
Description: Safety analysis set: all participants who provided informed consent, were randomized to treatment, and took at least 1 dose of IMP.
Frequency Threshold: 4
Time Frame: Day 1 through Day 57
Study: NCT02006628
Study Brief: A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GWP42003 1000 mg/Day Participants received GWP42003 (100 mg/mL), 5 mL BID administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks. None None 0 43 8 43 View
Placebo Participants received placebo (0 mL CBD), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks. None None 1 45 10 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.1 View