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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT03072459
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
Study: NCT03072459
Study Brief: A Retrospective Study of the Navio Robotic-assisted Surgical System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Navio Robotic-assisted Surgical System Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system. 0 None 2 128 28 128 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep venous thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lower extremity DVT SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Radiolucency line tibial ML zone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Redness, burning, itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Effusion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling and discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Slight swelling and edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Knee pain due to mild iliotibial band tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in quadriceps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain with 50 mL of blood aspiration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Possible cellulitis - not life threatening SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Manipulation under anesthesia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Occasional swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Soreness/pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Incisional soreness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pin site drainage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pimple drainage from pin site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stress shielding SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Radiolucent lines SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Femoral osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Incision pain with deep flexion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anterior knee pain and swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Synovial hypertrophy, quadriceps atrophy, and knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hamstring irritation and ischial tuberosity bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin irritation over pin site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View