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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003608-38 | EudraCT Number |
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The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic kidney disease (CKD) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (HU/HC) prescription (Yes/No). The CKD risk categories used for stratification were based on both Estimated glomerular filtration rate(eGFR) and albuminuria assessed by Albumin/creatinine ratio (ACR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crizanlizumab + standard of care | Experimental | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
|
| standard of care | Active Comparator | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizanlizuamb | Drug | Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months | The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months | The effect of SEG101 on clinical disease activity was measured by the change in albuminuria (ACR) between baseline and month 3, baseline and month 6, baseline and month 9, baseline and month 12. A reduction from baseline indicates improvement in patients. | Baseline to 3, 6, 9, and 12 months |
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Inclusion Criteria:
Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients < 18)
Patients with ACR of ≥ 100 to < 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, and platelet count ≥ 75 x 10^9/L
Adequate hepatic function as defined by:
Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Illinois Hospital and Health Sciences System . |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40569673 | Derived | Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26. | |
| 37254256 | Derived | Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
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Patients were stratified at randomization based on CKD risk category (moderate risk or high/very high risk) and HU/HC use (Yes/No).
At visit "Week 1 Day 1" all eligible patients were randomized via Interactive Response Technology (IRT) to one of the treatment arms.
Patients were enrolled in 24 centers in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crizanlizumab + Standard of Care | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
| FG001 | Standard of Care (SOC) |
| 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 | Dec 2, 2021 | Mar 20, 2024 |
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|
| Standard of Care | Drug | HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker) |
|
| Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months | The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 6. A reduction from baseline indicates improvement in patients. | Baseline to 6 months |
| Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months | The effect of SEG101 on clinical disease activity was measured by counting patients who had Stable PCR: within ± 20% change from baseline to month 12. PCR improvement: ≥ 20% decrease in PCR from baseline indicates improvement in patients. | Baseline to 12 months |
| Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | The percentage change in eGFR was calculated as the post-baseline eGFR value minus the baseline eGFR divided by the eGFR at baseline. A reduction from baseline indicates improvement in participants. | Baseline to 3, 6, 9, and 12 months |
| Slope of Albumin to Creatinine Ratio (ACR) Decline | The effect of SEG101 on clinical disease activity was measured by the slope of ACR decline between baseline and Month 12. A reduction from baseline indicates improvement in patients. | Baseline to 12 months |
| Slope of Estimated Glomerular Filtration Rate (eGFR) Decline | The effect of SEG101 on clinical disease activity was measured by the slope of eGFR between baseline and Month 12. The calculation of eGFR is based on the chronic kidney disease epidemiology collaboration (CKD-EPI) (for patients ≥ 18) and Creatinine-based "Bedside Schwartz" (for patients < 18) equations. A reduction in drop rate from baseline indicates improvement in patients. | Baseline to 12 months |
| Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months | The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in participants. CKD progression is defined as an increase in CKD progression category, a 25% or greater drop in eGFR from baseline or at least 50% increase in ACR for patients with severe (A3) albuminuria and a doubling of albumin levels in patients with moderate (A2) albuminuria. | Baseline to 12 months |
| Shift Table for Chronic Kidney Disease (CKD) Progression | The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in patients. | Baseline and month 12 |
| Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab | The effect of SEG101 on clinical disease activity was measured by percentage of participants shifted to different worst post-baseline categories between baseline and Month 12. An increase in percentage shifting from higher category to lower category indicates improvement in patients. Baseline is defined as the last non-missing value prior to the first dose. | Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months |
| Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations | The effect of SEG101 on clinical disease activity was measured by summarizing the annualized rate of visits to ER and hospitalizations between baseline and 1 year 4 months. Annualized rate of hospitalizations and ER visits due to VOC =(Number of ER or hospitalizations reported until End date x 365.25)/(End date-date of first dose of study treatment+1). A reduction from baseline indicates improvement in patients. | Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months |
| Mean Serum Concentration (Ctrough) of Crizanlizumab | The effect of SEG101 on clinical disease activity was measured by checking the concentration of the Drug in serum at different time points. Crizanlizumab pre-dose/trough pharmacokinetic samples were taken at select time points. | Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1 |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Our Lady of the Lake Regional Medic . | Baton Rouge | Louisiana | 70809 | United States |
| East Carolina University BrodySchool of Med 3 | Greenville | North Carolina | 27858 | United States |
| Univ of Tenn Health Sciences Ctr | Memphis | Tennessee | 38163 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 20.211-030 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01232-010 | Brazil |
| Novartis Investigative Site | Porto Alegre | 90035-003 | Brazil |
| Novartis Investigative Site | Créteil | 94010 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Larissa | 41221 | Greece |
| Novartis Investigative Site | Dublin | DO8 | Ireland |
| Novartis Investigative Site | Tripoli | 1434 | Lebanon |
| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Novartis Investigative Site | Panama City | 0801 | Panama |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Adana | 01250 | Turkey (Türkiye) |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Antakya / Hatay | 31100 | Turkey (Türkiye) |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Novartis Investigative Site | London | W12 0HS | United Kingdom |
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
| Entered Post-treatment Follow-up, Discontinued |
|
| Did Not Enter Post-treatment Follow-up |
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| Not Treated |
|
| COMPLETED | Completed = completed treatment Not Completed = discontinued treatment |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Crizanlizumab + Standard of Care | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
| BG001 | Standard of Care (SOC) | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Number | 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 | Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months | The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline to 12 months |
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| Secondary | Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months | The effect of SEG101 on clinical disease activity was measured by the change in albuminuria (ACR) between baseline and month 3, baseline and month 6, baseline and month 9, baseline and month 12. A reduction from baseline indicates improvement in patients. | Participants in the FAS with an available assessment for the outcome measure at baseline and at each timepoint. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Mean | Standard Deviation | mg/g | Baseline to 3, 6, 9, and 12 months |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months | The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 6. A reduction from baseline indicates improvement in patients. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline to 6 months |
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| Secondary | Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months | The effect of SEG101 on clinical disease activity was measured by counting patients who had Stable PCR: within ± 20% change from baseline to month 12. PCR improvement: ≥ 20% decrease in PCR from baseline indicates improvement in patients. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline to 12 months |
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| Secondary | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | The percentage change in eGFR was calculated as the post-baseline eGFR value minus the baseline eGFR divided by the eGFR at baseline. A reduction from baseline indicates improvement in participants. | Participants in the FAS with an available assessment for the outcome measure at baseline and at each timepoint. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Mean | Standard Deviation | Percentage change in eGFR | Baseline to 3, 6, 9, and 12 months |
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| Secondary | Slope of Albumin to Creatinine Ratio (ACR) Decline | The effect of SEG101 on clinical disease activity was measured by the slope of ACR decline between baseline and Month 12. A reduction from baseline indicates improvement in patients. | Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Least Squares Mean | Standard Error | mg/g per month | Baseline to 12 months |
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| Secondary | Slope of Estimated Glomerular Filtration Rate (eGFR) Decline | The effect of SEG101 on clinical disease activity was measured by the slope of eGFR between baseline and Month 12. The calculation of eGFR is based on the chronic kidney disease epidemiology collaboration (CKD-EPI) (for patients ≥ 18) and Creatinine-based "Bedside Schwartz" (for patients < 18) equations. A reduction in drop rate from baseline indicates improvement in patients. | Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Least Squares Mean | Standard Error | mL/min/1.73 m^2 per month | Baseline to 12 months |
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| Secondary | Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months | The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in participants. CKD progression is defined as an increase in CKD progression category, a 25% or greater drop in eGFR from baseline or at least 50% increase in ACR for patients with severe (A3) albuminuria and a doubling of albumin levels in patients with moderate (A2) albuminuria. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline to 12 months |
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| Secondary | Shift Table for Chronic Kidney Disease (CKD) Progression | The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in patients. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline and month 12 |
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| Secondary | Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab | The effect of SEG101 on clinical disease activity was measured by percentage of participants shifted to different worst post-baseline categories between baseline and Month 12. An increase in percentage shifting from higher category to lower category indicates improvement in patients. Baseline is defined as the last non-missing value prior to the first dose. | Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Number | Percentage of participants | Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months |
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| Secondary | Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations | The effect of SEG101 on clinical disease activity was measured by summarizing the annualized rate of visits to ER and hospitalizations between baseline and 1 year 4 months. Annualized rate of hospitalizations and ER visits due to VOC =(Number of ER or hospitalizations reported until End date x 365.25)/(End date-date of first dose of study treatment+1). A reduction from baseline indicates improvement in patients. | The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Mean | Standard Deviation | ER or hospitalizations/year | Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months |
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| Secondary | Mean Serum Concentration (Ctrough) of Crizanlizumab | The effect of SEG101 on clinical disease activity was measured by checking the concentration of the Drug in serum at different time points. Crizanlizumab pre-dose/trough pharmacokinetic samples were taken at select time points. | Participants in the FAS with an available assessment for the outcome measure at baseline and up to 12 months. The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1 |
|
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Adverse events (AEs) were collected from first dose of study treatment to 105 days after the last dose of study treatment with a median duration of exposure to crizanlizumab of 50.1 weeks.
Any sign or symptom that occurs during conduct of the trial & safety follow-up. Other AE: AE that is not an SAE, meaning it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity, or interfere substantially with normal life functions & does not cause a congenital anomaly or birth defect. 1 subject randomized to the Crizanlizumab + Standard of Care arm was not treated.
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 | Crizanlizumab + Standard of Care | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment | 0 | 29 | 2 | 29 | 21 | 29 |
| EG001 | Standard of Care (SOC) | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. | 0 | 28 | 2 | 28 | 19 | 28 |
| EG002 | All Participants | All Participants enrolled in the trial from whom safety was collected. | 0 | 57 | 4 | 57 | 40 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
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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 pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-3000 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2023 | Mar 20, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D051436 | Renal Insufficiency, Chronic |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
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| Multiple |
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