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 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 10:42 PM
NCT ID: NCT02958267
Description: Included in this report are any adverse events considered unexpected and therefore not listed on the research protocol and informed consent documents as common or likely, less common, or rare risks.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of informed consent/enrollment through approximately 12 months following each participant's treatment date or until participant withdrawal, whichever occurred first.
Study: NCT02958267
Study Brief: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis 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
Gel-One® Hyaluronate Injection Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. 0 None 0 15 0 15 View
BMAC Injection and PRP Injection Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. 0 None 0 17 1 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View