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: 2025-12-25 @ 12:11 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT00315458
Description: AEs were learned of through spontaneous reports and subject interview.
Frequency Threshold: 4.50
Time Frame: Subjects with AEs that were ongoing at subject's last study visit were followed until resolution or 30 days after last visit, whichever came first. AEs reported during 7 days following last visit were followed until resoultion or 30 days after last visit.
Study: NCT00315458
Study Brief: Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double-blind Placebo Patch Reference Treatment placebo 10 or 20 applied for 7-day wear None None 1 51 14 51 View
Double-blind BTDS 10/20 Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear None None 2 56 22 56 View
Run-in Period Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear None None 1 159 60 159 View
Overall BTDS Exposure Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase. None None 5 159 82 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (5.1) View
Acute myocardial infarction - DEATH SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (5.1) View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (5.1) View
Acute exacerbation of COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (5.1) View
Recurrent Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (5.1) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (5.1) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (5.1) View
Near Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (5.1) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (5.1) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (5.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (5.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (5.1) View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA (5.1) View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (5.1) View
Application site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA (5.1) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (5.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (5.1) View
Sweating Increased SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (5.1) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (5.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (5.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (5.1) View