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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:56 PM
NCT ID: NCT05319756
Description: Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dose were counted under the previous treatment visit
Frequency Threshold: 0
Time Frame: During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 treatment periods, and it lasted up to approximately 13 weeks.
Study: NCT05319756
Study Brief: Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gabapentin 1200 mg and Oxycodone HCl 20 mg Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg 0 None 0 52 2 52 View
Placebo Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl 0 None 0 53 0 53 View
Oxycodone HCl 20 mg Single Dose Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin 0 None 0 52 4 52 View
Gabapentin 600 mg Single Dose Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl 0 None 0 51 0 51 View
Gabapentin 1200 mg Single Dose Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl 0 None 0 52 2 52 View
Gabapentin 600 mg and Oxycodone HCl 20 mg Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg 0 None 0 52 4 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.1) View