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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT02984228
Description: Adverse events included bleeding from the injection site, swelling, infection, allergic reactions, weakness of the muscle surrounding the infected joint. The adverse event percentages noted in this section do not match the ones reported under Outcome Measures, as the Outcome Measures represent the percentage of adverse event cases among all events available (e.g., number of patients \* number of follow-up time points).
Frequency Threshold: 0
Time Frame: Adverse event data were collected over 1 year.
Study: NCT02984228
Study Brief: Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Platelet-rich Plasma (PRP) Patients will receive an injection of PRP. PRP Ultrasound 0 None 0 34 11 34 View
Hyaluronic Acid Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound 0 None 0 35 13 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weakness of muscle surrounding injection site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Allergic reaction with itchiness NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Difficulty moving affected shoulder joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View