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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00312195
Description: Adverse Events were learned of through spontaneous reports and subject interview.
Frequency Threshold: 4.50
Time Frame: Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Study: NCT00312195
Study Brief: Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant 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
Open-label Run-in Period BTDS 5, 10 or 20 Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear. None None 7 588 245 588 View
Double-blind Placebo Patch Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. None None 0 138 21 138 View
Double-blind BTDS Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear. None None 0 129 25 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain abdominal SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Abscess SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Injury accidental SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Cellulitis SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Pain, chest SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Fibrillation, atrial SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART (5.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Immune system disorders COSTART (5.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART (5.0) View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders COSTART (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART (5.0) View
Vomit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART (5.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART (5.0) View
Erythema at site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART (5.0) View
Pruritus at site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART (5.0) View