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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT04012567
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected upon device implantation through 24 months, approximately 740 days.
Study: NCT04012567
Study Brief: Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
The BIOSURE HA Interference Screw The Biosure HA Interference Screw, an absorbable screw made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Control device: BIOSURE HA Interference Screw: BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion. 0 None 3 70 26 70 View
The Biosure Regenesorb Interference Screw The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Investigational device: Biosure Regenesorb Interference Screw: The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing. 0 None 3 69 30 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombosis:middle & lower left superficial femoral, popliteal, posterior tibial,& intermuscular vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anterior cruciate ligament injury in right knee, meniscus injury in right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Prepuce balanitis, prepuce too long SYSTEMATIC_ASSESSMENT General disorders None View
Meniscus Injury of the right knee SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Left knee anterior cruciate ligament rupture,lateral meniscus root tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foreign body reaction SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pharyngeal disorder SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INJURY OF POSTERIOR HORN OF MENISCUS ON THE LEFT KNEE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
WOUND PAIN SYSTEMATIC_ASSESSMENT General disorders None View
FLAT WART SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders None View
PERIFOLLICULAR KERATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
WOUND PAIN SYSTEMATIC_ASSESSMENT General disorders None View
HYPERCHOLESTEROLEMIA SYSTEMATIC_ASSESSMENT Endocrine disorders None View
OSTEOPOROSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SYMPTOMS OF LOW GRADE FEVER SYSTEMATIC_ASSESSMENT General disorders None View
HYPERURICEMIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ACROMIAL IMPINGEMENT SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SWELLING OF LEFT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
RIGHT PLANTAR FASCIITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
UPPER RESPIRATORY INFECTION (URI) SYSTEMATIC_ASSESSMENT Infections and infestations None View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
LIGAMENT STRAIN IN LEFT KNEE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
INSOMNIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MENSTRUAL DISORDER SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
LEFT PLANTAR FASCIITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
POSTOPERATIVE ANESTHESIA GASTROINTESTINAL REACTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
POSSIBLE HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Endocrine disorders None View
FEVER SYSTEMATIC_ASSESSMENT General disorders None View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
FREQUENT URINATION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
QUADRICEPS ATROPHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
JOINT PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LARYNGOPHARYNGITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ANXIETY STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
SOFT TISSUE STRAINS OF RIGHT FOOT SYSTEMATIC_ASSESSMENT General disorders None View
SWELLING IN THE LEFT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
QUADRICEPS ATROPHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders None View
RIGHT KNEE OSTEOARTHRITIS AGGRAVATED SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CHRONIC GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CONJUNCTIVITIS OF THE RIGHT EYE SYSTEMATIC_ASSESSMENT Eye disorders None View
NASAL BLEEDING SYSTEMATIC_ASSESSMENT Vascular disorders None View
INCISION REDNESS AND SWELLING SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SYNOVITIS OF THE RIGHT KNEE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
FOCAL NODULAR HYPERPLASIA OF LIVER SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
DISUSE OSTEOPOROSIS OF THE RIGHT KNEE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
RIGHT QUADRICEPS FEMORIS MUSCLE ATROPHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SWELLING IN THE RIGHT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
LEFT QUADRICEPS ATROPHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SLIGHT SWELLING OF THE LEFT KNEE JOINT SYSTEMATIC_ASSESSMENT General disorders None View
SYMPTOMS OF FEVER SYSTEMATIC_ASSESSMENT General disorders None View
SOFT TISSUE CONTUSION OF LEFT KNEE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
TENOSYNOVITIS STENOSANS OF STYLOID PROCESS OF RADIUS OF LEFT WRIST SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
IRREGULAR PERIODS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
FALL INDUCED PAIN IN RIGHT KNEE JOINT FOR 3 DAYS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
NUMBNESS IN THE MEDIAL LEG SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ANTERIOR TISSUE SWELLING OF RIGHT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
PAIN IN THE RIGHT KNEE JOINT CAUSED BY SPRAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BONE MARROW TUNNEL CYST OF THE RIGHT KNEE TIBIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
FEVER SYMPTOM SYSTEMATIC_ASSESSMENT General disorders None View
ECZEMATOID DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CHRONIC PHARYNGITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
POSTOPERATIVE DYSFUNCTION OF LEFT KNEE JOINT TRAUMA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN IN THE WOUND SYSTEMATIC_ASSESSMENT General disorders None View
ATROPHY OF THE QUADRICEPS FEMORIS OF THE LEFT LOWER EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GASTROESOPHAGEAL REFLUX SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TRAUMATIC ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
FOREIGN BODY REACTION SYSTEMATIC_ASSESSMENT General disorders None View
INFLAMMATION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
THROMBOSIS OF RIGHT LOWER EXTREMITY SYSTEMATIC_ASSESSMENT Vascular disorders None View
PALPITATE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HYPERLIPIDEMIA WITH ATHEROSCLEROSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT General disorders None View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FOLLICULITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SWELLING OF SOFT TISSUE AROUND THE LEFT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
SCROTAL INFLAMMATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
LEFT KNEE CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
DISUSE OSTEOPOROSIS OF THE LEFT KNEE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
RIGHT KNEE PAIN SYSTEMATIC_ASSESSMENT General disorders None View
RIGHT KNEE EFFUSION SYSTEMATIC_ASSESSMENT General disorders None View
SWELLING IN THE RIGHT LOWER EXTREMITY SYSTEMATIC_ASSESSMENT General disorders None View
OOR MOTION OF THE RIGHT KNEE JOINT (LACK OF EXERCISE AFTER SURGERY) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
QUADRICEPS ATROPHY OF THE RIGHT LOWER LIMB SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
RIGHT RADIAL STYLOIDITIS SYSTEMATIC_ASSESSMENT General disorders None View
CHRONIC VAGINITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
SKIN PAPILLOMA（ FLAT WARTS) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
POSTOPERATIVE JOINT HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
CHRONIC PROSTATITIS SYSTEMATIC_ASSESSMENT General disorders None View
HYPERLIPIDEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
THYROID NODULE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
SECONDARY OLIGOMENORRHEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
FEVER SYSTEMATIC_ASSESSMENT General disorders None View
ANTERIOR TISSUE SWELLING OF RIGHT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
KNEE PAIN IN RIGHT KNEE SYSTEMATIC_ASSESSMENT General disorders None View
MAMMARY PAIN SYSTEMATIC_ASSESSMENT General disorders None View
RIGHT KNEE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
RIGHT QUADRICEPS ATROPHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ACUTE UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
CAT SCRATCH SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINE OCCULT BLOOD SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
VERRUCA VULGARIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT General disorders None View
CONJUNCTIVITIS OF BOTH EYES SYSTEMATIC_ASSESSMENT Eye disorders None View