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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT01256450
Description: Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
Frequency Threshold: 5
Time Frame: From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Study: NCT01256450
Study Brief: Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OL Buprenorphine HCl Buccal Film Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period None None 1 330 163 330 View
DB Placebo Film Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period None None 0 118 28 118 View
DB Buprenorphine HCl Buccal Film Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period None None 1 117 36 117 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BLOOD CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
CEREBROVASCULAR ACCIDENT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
ACUTE RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View