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 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT01270659
Description: None
Frequency Threshold: 0
Time Frame: All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
Study: NCT01270659
Study Brief: Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-FBT Subject will receive FBT and placebo at a low dose Fentanyl: Fentanyl buccal tablet 100 mcg once 0 None 0 6 1 6 View
High-FBT Subject will receive the high dose regimen of FBT and a high dose placebo Fentanyl: Fentanyl buccal tablet 200 mcg once 0 None 0 25 9 25 View
Low Control Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once 0 None 0 4 3 4 View
High Control Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time 0 None 0 25 10 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View