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 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
NCT ID:
NCT04300751
Description:
AE definitions are the same as the clnicaltrials.gov definitions.
Frequency Threshold:
0
Time Frame:
Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.
Study:
NCT04300751
Study Brief:
The Behavioral Effects of Opioids and Alcohol
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pre-Intervention / Days Off | Prior to any drug administration or on participant days off when AE is not related to drug conditions. | 0 | None | 0 | 11 | 4 | 11 | View |
| Qualification: Oxycodone 30mg / Placebo | Prior to the experimental conditions, participants will receive a non-therapeutic dose of oxycodone 30 mg, p.o. during a qualifying day session. This session serves as a responsive challenge which is intended to confirm that subjects are able to detect the active drug. | 0 | None | 0 | 11 | 2 | 11 | View |
| Placebo/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 1 | 10 | View |
| Oxycodone 20mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 11 | 0 | 11 | View |
| Oxycodone 40mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 1 | 10 | View |
| Placebo/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 1 | 10 | View |
| Placebo/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 1 | 10 | View |
| Oxycodone 20mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 0 | 10 | View |
| Oxycodone 20mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 11 | 0 | 11 | View |
| Oxycodone 40mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 0 | 10 | View |
| Oxycodone 40mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | None | 0 | 10 | 0 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Sinus Symptoms | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Generalized Body Aches | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea / Vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Tooth Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |