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 @ 4:19 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT00398866
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00398866
Study Brief: A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bupivicaine Bupivicaine (local anesthetic) Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks None None 1 66 2 66 View
Triamcinolone Corticosteroid (triamcinolone (Kenalog) 40 mg) Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation None None 0 68 10 68 View
Hylan G-F 20 Synvisc Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks None None 2 66 3 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall--hand injury None Injury, poisoning and procedural complications None View
Emergency Cholecystecomy None Gastrointestinal disorders None View
Mitral Valve Surgery None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Atrophy or Depigmentation None Skin and subcutaneous tissue disorders None View
Pain, Swelling, or Numbness in Hand None Musculoskeletal and connective tissue disorders None View
Skin and Nail Abnormalities None Skin and subcutaneous tissue disorders None View
Positive ANA Test (Previous status unknown) None Immune system disorders None View