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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT00669032
Description: Treatment safety and tolerability was evaluated based on the incidence and type of adverse events and the results of blood laboratory tests and physical examinations throughout the duration of the study. Safety analyses were performed in those patients who received at least one intra-articular injection (safety population).
Frequency Threshold: 0
Time Frame: 40 months
Study: NCT00669032
Study Brief: Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee
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 Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. None None 0 153 11 153 View
Hyaluronic Acid (Adant) Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. None None 0 153 11 153 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (Unspecified) View
Pain at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Bleeding at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Heaviness feeling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View