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 @ 3:42 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT02610192
Description: Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Frequency Threshold: 0
Time Frame: month 1, month 3, month 6 and month 12
Study: NCT02610192
Study Brief: nSTRIDE APS in Females With Primary Patellofemoral 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
nSTRIDE APS Intra-articular Injection of Autologous Protein Solution (APS) 0 None 3 50 39 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Excessive Injection Site Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Effusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in calf NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sprain muscle leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
burning feeling lower limb-foot NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
kahler disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Stifness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fall on knee causing pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
inflammation pes anserinus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
knee twist causing medial bone edema NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee overload NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain meniscus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain on the medial side due medial root tear NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
worsening OA symptoms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
wrong movement causing knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View