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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT00403234
Description: AEs were learned of through spontaneous reports and subject interview.
Frequency Threshold: 4.5
Time Frame: Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
Study: NCT00403234
Study Brief: Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo transdermal patch applied for 7-day wear. None None 0 2 2 2 View
BTDS 10 Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear None None 0 3 2 3 View
BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear None None 0 3 3 3 View
BTDS 30 Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear None None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Gamma-Glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Dysphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View