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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT03317834
Description: The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
Frequency Threshold: 0
Time Frame: Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
Study: NCT03317834
Study Brief: Navio With Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Population Total Knee Replacement with Navio Surgical Systems Navio ™ Robotic-assisted Surgical System: Total Knee Replacement 2 None 26 122 12 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Recurrent dislocation, right hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Quadricep tendon rupture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Delayed wound healing SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arthrofibrosis of total knee arthroplasty SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthrofibrosis right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Instability of internal left knee prosthesis, init. encounter SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Patellar tendon tear right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Prostate cancer (reoccurence) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Deceased, unknown cause SYSTEMATIC_ASSESSMENT Investigations None View
Rt knee effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ischemic stroke in left MCA region SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary atelectasis J98.11 SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Right ankle fracture SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Periprosthetic infection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Macular Pucker with surgical repair SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders None View
Right knee pain, lumbar sprain / strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall causing torn tendon SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection right knee SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acquired instability, left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthrofibrosis (R) knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left stiffness of knee with history of replacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthrofibrosis left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth abcess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wound complication due to suture reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain in left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in left hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right knee pain, lumbar sprain / strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in right knee, effusion right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Iliotibial band friction syndrome - left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View