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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT03705559
Description: None
Frequency Threshold: 0
Time Frame: 4 Weeks
Study: NCT03705559
Study Brief: Opioid and Cannabinoid Interactions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo/Placebo Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) 0 None 0 9 4 9 View
THC 10mg/Placebo Opioid Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) 0 None 0 9 0 9 View
THC 30mg/Placebo Opioid Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) 0 None 0 9 1 9 View
Oxycodone 15mg/Placebo Marijuana Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) 0 None 0 9 2 9 View
Oxycodone 30mg/Placebo Marijuana Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) 0 None 0 9 2 9 View
TCH 10mg/Oxycodone 15mg Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally 0 None 0 9 0 9 View
TCH 10mg/Oxycodone 30mg Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally 0 None 0 9 3 9 View
TCH 30mg/Oxycodone 15mg Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally 0 None 0 9 2 9 View
TCH 30mg/Oxycodone 30mg Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally 0 None 0 9 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Eye Dryness SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Nose SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Body Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View