Adverse Events Module

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 @ 4:19 AM
Ignite Modification Date: 2025-12-26 @ 3:20 AM
NCT ID: NCT02370420
Description: All patients were asked and evaluated for possibles adverse events at time-points of evaluation (most commonly pain at the site of injection). Specific attention was provided for platelet-rich plasma (PRP) treated patients.
Frequency Threshold: 0
Time Frame: Six months
Study: NCT02370420
Study Brief: Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Triple Application of PRP Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home 0 None 0 15 1 15 View
Unique Application of PRP Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home 0 None 0 15 1 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain, inflammation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View