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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
| Horizon 2020 - European Commission | OTHER |
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants |
|
| Cohort 2 | Experimental | VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC-02 Combination Product | Combination Product | PEC-01 cells loaded into a Delivery Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All AEs in Cohort 1 Participants | Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen. | Enrollment (Visit 3, Day 1) through the Month 4 Visit |
| Change in C-peptide for Cohort 2 Subjects | Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test. | Baseline to Week 26 Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gautham Marigowda | Vice President, Clinical Development, Vertex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| UCLA-UCI Alpha Stem Cell Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38012450 | Derived | Keymeulen B, De Groot K, Jacobs-Tulleneers-Thevissen D, Thompson DM, Bellin MD, Kroon EJ, Daniels M, Wang R, Jaiman M, Kieffer TJ, Foyt HL, Pipeleers D. Encapsulated stem cell-derived beta cells exert glucose control in patients with type 1 diabetes. Nat Biotechnol. 2024 Oct;42(10):1507-1514. doi: 10.1038/s41587-023-02055-5. Epub 2023 Nov 27. | |
| 35028608 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device |
| FG001 | Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2020 | Oct 12, 2024 |
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There are two Cohorts in this study design. Cohort 1 was to enroll up to 15 subjects total. After Cohort 1 enrollment was completed, Cohort 2 was to enroll up to an additional 60 subjects.
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| Irvine |
| California |
| 92697 |
| United States |
| UC Davis - Alpha Stem Cell Clinic | Sacramento | California | 95817 | United States |
| University of California San Diego | San Diego | California | 92121 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Ohio State University | Columbus | Ohio | 43203 | United States |
| University Hospital Brussels | Brussels | Belgium |
| University of Alberta | Edmonton | Alberta | Canada |
| University of British Columbia | Vancouver | British Columbia | Canada |
| Shapiro AMJ, Thompson D, Donner TW, Bellin MD, Hsueh W, Pettus J, Wilensky J, Daniels M, Wang RM, Brandon EP, Jaiman MS, Kroon EJ, D'Amour KA, Foyt HL. Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device. Cell Rep Med. 2021 Dec 2;2(12):100466. doi: 10.1016/j.xcrm.2021.100466. eCollection 2021 Dec 21. |
| 34861146 | Derived | Ramzy A, Thompson DM, Ward-Hartstonge KA, Ivison S, Cook L, Garcia RV, Loyal J, Kim PTW, Warnock GL, Levings MK, Kieffer TJ. Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes. Cell Stem Cell. 2021 Dec 2;28(12):2047-2061.e5. doi: 10.1016/j.stem.2021.10.003. |
VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants.
VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device |
| BG001 | Cohort 2 | VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants. VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Duration of Type 1 Diabetes | Number of years from onset of type 1 diabetes to the informed consent date, rounded to the nearest integer. | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of All AEs in Cohort 1 Participants | Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen. | Posted | Number | Adverse Events | Enrollment (Visit 3, Day 1) through the Month 4 Visit |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in C-peptide for Cohort 2 Subjects | Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test. | Posted | Mean | Standard Deviation | ng*hour/mL | Baseline to Week 26 Visit |
|
|
Adverse events were reported for Cohort 1 participants from date of enrollment through week 26. Adverse events were reported for Cohort 2 participants from date of enrollment through week 104.
AEs were reported on a CRF at visit 2 (Wk -4) and at every subsequent visit through end of study. The definitions used for classifying AEs/SAEs are consistent with clinicaltrials.gov definitions. Adverse Events of Special Interest (AESIs) are defined as AEs that lead to the unexpected or premature explantation of VC-02-300 or sentinel units, AEs that result in early withdrawal from study, and severe hypoglycemic events occurring after VC-02 implantation possibly or definitely related to VC-02.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Cohort 2 | VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants. VC-02 Combination Product: PEC-01 cells loaded into a Delivery Device | 0 | 47 | 19 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma, post-procedural | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic Retinopathy | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver Abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Parvovirus B19 Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Incision Site Hematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post-procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post Procedural Hypotension | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post Operative Ileus | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | medDRA 24.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | medDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | medDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | medDRA 24.1 | Systematic Assessment |
| |
| Eustachian tube obstruction | Ear and labyrinth disorders | medDRA 24.1 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | medDRA 24.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | medDRA 24.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | medDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | medDRA 24.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Ulcerative gastritis | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Application site discomfort | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Application site rash | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Application site vesicles | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Feeling jittery | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Implant site extravasation | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Implant site irritation | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Implant site pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Infusion site bruising | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | medDRA 24.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Sensitisation | Immune system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Root canal infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | medDRA 24.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site discharge | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site haematoma | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site hypoaesthesia | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site inflammation | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site pruritus | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Incision site swelling | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural contusion | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural pruritus | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | medDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood magnesium increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Drug level above therapeutic | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Immunosuppressant drug level increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | medDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment | This non-serious, adverse event was classified as an Adverse Event of Special Interest (AESI). This hypoglycemic event was considered severe and possibly related to the IP. |
|
| Hypokalaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | medDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA 24.1 | Systematic Assessment |
| |
| Eye naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA 24.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Ophthalmic migraine | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | medDRA 24.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | medDRA 24.1 | Systematic Assessment | One (1) of the Device Dislocation, non-serious, adverse events was classified as an Adverse Event of Special Interest (AESI). The event was considered an AESI because it led to a premature explantation of a VC-02 unit. |
|
| Device extrusion | Product Issues | medDRA 24.1 | Systematic Assessment | Two (2) of the Device Extrusion, non-serious, adverse events were classified as Adverse Events of Special Interest (AESIs). The events were considered an AESIs because they led to premature explantation of VC-02 units. |
|
| Device power source issue | Product Issues | medDRA 24.1 | Systematic Assessment |
| |
| Drug delivery system issue | Product Issues | medDRA 24.1 | Systematic Assessment | This event was classified as an AESI. One of the participant's implanted VC-02 units exhibited lumen expansion due to accumulation of cartilage, likely graft-derived. Device integrity was maintained. This event led to premature explantation. |
|
| Anxiety | Psychiatric disorders | medDRA 24.1 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | medDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | medDRA 24.1 | Systematic Assessment |
| |
| Poor quality sleep | Psychiatric disorders | medDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Bladder discomfort | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | medDRA 24.1 | Systematic Assessment |
| |
| Adnexa uteri cyst | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nipple exudate bloody | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Uterine cyst | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | medDRA 24.1 | Systematic Assessment |
| |
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | medDRA 24.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | medDRA 24.1 | Systematic Assessment |
| |
| Fasciectomy | Surgical and medical procedures | medDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | medDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | medDRA 24.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | medDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gautham Marigowda | Vertex Pharmaceuticals, Inc | 617-961-0568 | gautham_marigowda@vrtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2021 | Oct 11, 2024 | SAP_001.pdf |
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| United States |
|
| Title | Measurements |
|---|---|
|
| Adverse Events Related to Immunosuppression |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|