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The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | CFZ533 administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Regimen B | Experimental | CFZ533 administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction |
|
| Regimen C | Active Comparator | Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFZ533 | Biological |
| ||
| Tacrolimus (Tac) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cmax Pharmacokinetic Parameter- Part I | Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I | Day 1 |
| Mean Tmax Pharmacokinetic Parameter - Part I | Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. | Day 1 |
| Mean AUClast Pharmacokinetic Parameter - Part I | Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. | Day 1 |
| Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II | To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale. An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy. | 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1 | To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154 | Baseline to end of study (Day 1, Day 29, Day 337) |
| Free CD40 and Total CD40 on B Cells - Part II |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aurora | Colorado | 80045 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Study Part 1 focused on measuring the multiple-dose safety, tolerability, PK, and PD of both IV and SC CFZ533 when administered with the SoC treatment regimen.
Study Part 2 investigated efficacy, safety, tolerability, PK and PD of CFZ533 in the absence of Tac.
In Part 1, patients were enrolled into Arm 1. In Part 2, patients were randomized (2:1) to Arms 2A and 2B.
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| ID | Title | Description |
|---|---|---|
| FG000 | CFZ533 + TAC + MMF (Part 1) | CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| FG001 | CFZ533 + MMF (Part 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 | Sep 20, 2017 | Nov 28, 2018 |
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|
| Mycophenolate mofetil (MMF) | Drug |
|
| Corticosteroids (CS) | Drug |
|
| anti-IL2 Induction | Biological |
|
The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome |
| Baseline to end of study (Day 1/predose) |
| Anti-CFZ533 Antibodies - Part I | To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies | Baseline to end of study |
| Anti-CFZ533 Antibodies - Part II | To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies | Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion) |
| eGFR - Part II | Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula. eGFR: Estimated glomerular filtration rate | Day 1, Day 29, Day 337, |
| CFZ533 Plasma PK Concentrations - Part II | Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen. | throughout study period (day 84 to day 336) |
| Total sCD40 Plasma Concentrations - Part II | To quantify the change from baseline and recovery of peripheral blood total soluble CD40 | 12 months |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 5271 | United States |
| Novartis Investigative Site | Detroit | Michigan | 48202 | United States |
| Novartis Investigative Site | Livingston | New Jersey | 07039 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45267-0585 | United States |
| Novartis Investigative Site | São Paulo | São Paulo | 04038-002 | Brazil |
| Novartis Investigative Site | Berlin | D-13353 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Utrecht | The Netherlands | 3508 GA | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Rotterdam | 3000 CA | Netherlands |
CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction |
| FG002 | Tac + MMF (Part 2) | Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction] |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all patients that received at least one dose of study drug.
For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.
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| ID | Title | Description |
|---|---|---|
| BG000 | CFZ533 + TAC + MMF (Part 1) | CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| BG001 | CFZ533 + MMF (Part 2) | CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction |
| BG002 | Tac + MMF (Part 2) | Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction] |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Mean Cmax Pharmacokinetic Parameter- Part I | Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I | The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ug/mL | Day 1 |
|
|
| |||||||||||||||||||||||||
| Primary | Mean Tmax Pharmacokinetic Parameter - Part I | Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. | The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Median | Full Range | day | Day 1 |
|
| ||||||||||||||||||||||||||
| Primary | Mean AUClast Pharmacokinetic Parameter - Part I | Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. | The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | day*ug/mL | Day 1 |
|
| ||||||||||||||||||||||||||
| Primary | Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II | To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale. An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy. | PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | events | 3, 6, 9, and 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1 | To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154 | PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | ng/ml | Baseline to end of study (Day 1, Day 29, Day 337) |
|
| ||||||||||||||||||||||||||
| Secondary | Free CD40 and Total CD40 on B Cells - Part II | The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome | PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | MESF | Baseline to end of study (Day 1/predose) |
|
| ||||||||||||||||||||||||||
| Secondary | Anti-CFZ533 Antibodies - Part I | To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies | Safety analysis set included all patients that received at least one dose of study drug. | Posted | Number | anti-CFZ533 antibodies | Baseline to end of study |
|
| |||||||||||||||||||||||||||
| Secondary | Anti-CFZ533 Antibodies - Part II | To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies | Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined. | Posted | Number | anti-CFZ533 antibodies | Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion) |
|
| |||||||||||||||||||||||||||
| Secondary | eGFR - Part II | Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula. eGFR: Estimated glomerular filtration rate | Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined. | Posted | Mean | 90% Confidence Interval | ml/min | Day 1, Day 29, Day 337, |
|
| ||||||||||||||||||||||||||
| Secondary | CFZ533 Plasma PK Concentrations - Part II | Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen. | The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ug/mL | throughout study period (day 84 to day 336) |
|
| ||||||||||||||||||||||||||
| Secondary | Total sCD40 Plasma Concentrations - Part II | To quantify the change from baseline and recovery of peripheral blood total soluble CD40 | PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | ng/mL | 12 months |
|
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CFZ533 + TAC + MMF (Part 1) | CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS). | 0 | 7 | 4 | 7 | 7 | 7 |
| EG001 | CFZ533 + MMF (Part 2) | CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction | 0 | 34 | 21 | 34 | 33 | 34 |
| EG002 | Tac + MMF (Part 2) | Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction] | 0 | 18 | 12 | 18 | 18 | 18 |
| EG003 | Total | Total | 0 | 59 | 37 | 59 | 58 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Delayed graft function | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Graft loss | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye movement disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gingival recession | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Mucocutaneous candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Wound infection bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Delayed graft function | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wound haematoma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Drug level decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Polyomavirus test positive | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Phonophobia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Perinephric collection | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Perinephric oedema | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal tubular injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sterile pyuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2018 | Nov 28, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000626035 | iscalimab |
| D016559 | Tacrolimus |
| D014221 | Triamcinolone |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
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