Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000650-64 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferasirox | Other | All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deferasirox | Drug | Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Liver Iron Content (LIC) at 52 Weeks From Baseline | Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment | Baseline, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Baseline LIC>15 Achieving LIC<5 mg Fe/g dw | The percentage of participants with baseline LIC>15 mg Fe/g dw achieving an LIC <5 mg Fe/g dw during the study | 5 years |
| Time to Achieving LIC <5 mg Fe/g dw |
Not provided
Inclusion Criteria:
Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron concentration >/= 5 mg Fe/g dw Serum Ferritin >/= 300 ng/mL
Exclusion Criteria:
HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood transfusion 6 months prior to study start, significant proteinuria, creatinine clearance </= 40 ml/min, serum creatinine > ULN, ALT >5 x ULN, active hepatitis B or C, cirrhosis
Pediatrics Only:
A patient's weight of at least 20 kg is required to allow dosing of 5 mg/kg with one tablet of 125 mg
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nanning | Guangxi | 530021 | China | ||
| Novartis Investigative Site |
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.
Not provided
Not provided
Not provided
At least 117 patients were planned to be enrolled; 134 patients were enrolled.
At least 117 patients were planned to be enrolled; 134 patients were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Deferasirox | All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2019 | Jul 17, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Time to achieving LIC <5 mg Fe/g dw for participants with baseline LIC>15 mg Fe/g dw during the study
| 5 years |
| Time From Target LIC of 3 mg Fe/g dw to the First LIC ≥5 mg Fe/g dw in the Follow up Period | Time from the target LIC <3 mg Fe/g dw to the first LIC ≥5 mg Fe/g dw in the follow-up period | post-baseline, up to 260 weeks |
| Absolute Change in Health-related Outcomes Using Medical Outcomes Study Form 36 (SF-36v2) | The SF-36 is a self-administered questionnaire for adults (from 18 years of age) and contains 36 items which measure: Physical functioning, Role limitation due to physical health problems, Bodily pain, General health perceptions, Vitality, Social functioning, Role limitations due to emotional problems and General mental health . The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)]. | Baseline, 52, 104 & 156 Weeks |
| Absolute Change in Health-related Outcomes Using the Pediatric Quality of Life Questionnaire (PedsQL™) | The PedsQL™ is a modular approach to measuring health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL™ Generic Core Scales encompass the essential core domains for pediatric HRQOL measurement: 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items). The Generic Core Scales are designed to enable comparisons across patient and healthy populations. The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)]. | Baseline, 52, 104 & 156 Weeks |
| Absolute Change in LIC From Baseline Over Time | Absolute change in serum ferritin from baseline over time up to 260 weeks | 24, 52, 76, 104, 128, 156, 180, 208, 232, 260 Weeks |
| Serum Ferritin (SF) vs LIC at Baseline and EOS (Week 260 + 30 Days Follow-up) | Correlation between serum ferritin and LIC is assessed using scatter plots with pearson correlation coefficient and simple linear model. | Baseline, End of Study (EOS): Week 260 + 30 days follow up |
| Correlation Analysis for Absolute Change in LIC and Serum Ferritin at Week 24 and EOS (Week 260 + 30 Days Follow-up) | Correlation for absolute change between LIC and serum ferritin was assessed using scatter plots with pearson correlation coefficient and simple linear model. | Week 24, End of Study (EOS): Week 260 + 30 days follow up |
| Absolute Change in LIC From Baseline After 52 Weeks of Treatment by Underlying Non-transfusion Dependent Thalassemia (NTDT) Syndrome | Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment by underlying NTDT syndrome. The 4 underlying disease types: Beta-thalassemia intermedia (N =69), HbE beta-thalassemia (N = 24), Alpha-thalassemia intermedia (HbH disease) (N = 40), Other, specify (N = 1) | Baseline, 52 Weeks |
| Absolute Change in Serum Ferritin From Baseline After 52 Weeks | Absolute change in serum ferritin from baseline after 52 weeks of treatment | Baseline, 52 weeks |
| PK Parameters: AUCtau | The pharmacokinetic parameter, AUCtau was determined using non-compartmental method(s) for deferasirox and its iron complex. AUC=area under the concentration-time curve during a dosing interval at steady state (amount × time × volume). | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
| PK Parameters: Cmax | The pharmacokinetic parameter, Cmax, was determined using non-compartmental method(s) for deferasirox and its iron complex. Cmax (maximum/peak plasma drug concentration after drug administration)=amount × volume | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
| PK Parameters: Tmax | The pharmacokinetic parameter, Tmax, may be determined using non-compartmental method(s) for deferasirox and its iron complex. Tmax=time to reach maximum/peak concentration following drug administration. | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
| Plasma Pharmacokinetics (PK) Deferasirox Concentrations | Blood samples for PK evaluation were collected for a sub-group of patients. The patient had to have been on treatment without dose adjustment or treatment interruption (for any reason) for at least 4 consecutive days prior to scheduled PK sampling visit. If there was a dosage change or interruption within 4 days of the visit, no PK blood samples was collected, and an appropriate comment had to be made on the PK CRF page. | Weeks 12 & 24: pre-dose (0hr), 2hr & 4hr post-dose |
| Goudi-Athens |
| GR |
| 115 27 |
| Greece |
| Novartis Investigative Site | Cagliari | CA | 09121 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Hazmiyeh | Beirut | PO BOX 213 | Lebanon |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Tunis | 1006 | Tunisia |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | London | NW1 2PJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deferasirox | All patients were treated with 10mg/kg/day deferasirox with dose adjustments after 4 weeks of treatment according to baseline Liver Iron Concentration (LIC). |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Absolute Change in Liver Iron Content (LIC) at 52 Weeks From Baseline | Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | mg Fe/g dw | Baseline, 52 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Baseline LIC>15 Achieving LIC<5 mg Fe/g dw | The percentage of participants with baseline LIC>15 mg Fe/g dw achieving an LIC <5 mg Fe/g dw during the study | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Number | percentage of participants | 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Achieving LIC <5 mg Fe/g dw | Time to achieving LIC <5 mg Fe/g dw for participants with baseline LIC>15 mg Fe/g dw during the study | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Time From Target LIC of 3 mg Fe/g dw to the First LIC ≥5 mg Fe/g dw in the Follow up Period | Time from the target LIC <3 mg Fe/g dw to the first LIC ≥5 mg Fe/g dw in the follow-up period | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Median | 95% Confidence Interval | days | post-baseline, up to 260 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Absolute Change in Health-related Outcomes Using Medical Outcomes Study Form 36 (SF-36v2) | The SF-36 is a self-administered questionnaire for adults (from 18 years of age) and contains 36 items which measure: Physical functioning, Role limitation due to physical health problems, Bodily pain, General health perceptions, Vitality, Social functioning, Role limitations due to emotional problems and General mental health . The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)]. | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 52, 104 & 156 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Absolute Change in Health-related Outcomes Using the Pediatric Quality of Life Questionnaire (PedsQL™) | The PedsQL™ is a modular approach to measuring health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL™ Generic Core Scales encompass the essential core domains for pediatric HRQOL measurement: 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items). The Generic Core Scales are designed to enable comparisons across patient and healthy populations. The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)]. | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 52, 104 & 156 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Absolute Change in LIC From Baseline Over Time | Absolute change in serum ferritin from baseline over time up to 260 weeks | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | mg Fe/g dw | 24, 52, 76, 104, 128, 156, 180, 208, 232, 260 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Ferritin (SF) vs LIC at Baseline and EOS (Week 260 + 30 Days Follow-up) | Correlation between serum ferritin and LIC is assessed using scatter plots with pearson correlation coefficient and simple linear model. | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Number | correlation coefficient | Baseline, End of Study (EOS): Week 260 + 30 days follow up |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation Analysis for Absolute Change in LIC and Serum Ferritin at Week 24 and EOS (Week 260 + 30 Days Follow-up) | Correlation for absolute change between LIC and serum ferritin was assessed using scatter plots with pearson correlation coefficient and simple linear model. | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Number | correlation coefficient | Week 24, End of Study (EOS): Week 260 + 30 days follow up |
|
| |||||||||||||||||||||||||||
| Secondary | Absolute Change in LIC From Baseline After 52 Weeks of Treatment by Underlying Non-transfusion Dependent Thalassemia (NTDT) Syndrome | Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment by underlying NTDT syndrome. The 4 underlying disease types: Beta-thalassemia intermedia (N =69), HbE beta-thalassemia (N = 24), Alpha-thalassemia intermedia (HbH disease) (N = 40), Other, specify (N = 1) | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | mg Fe/g dw | Baseline, 52 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Absolute Change in Serum Ferritin From Baseline After 52 Weeks | Absolute change in serum ferritin from baseline after 52 weeks of treatment | The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 52 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameters: AUCtau | The pharmacokinetic parameter, AUCtau was determined using non-compartmental method(s) for deferasirox and its iron complex. AUC=area under the concentration-time curve during a dosing interval at steady state (amount × time × volume). | The PK analysis set consisted of all patients from FAS who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*umol/L | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameters: Cmax | The pharmacokinetic parameter, Cmax, was determined using non-compartmental method(s) for deferasirox and its iron complex. Cmax (maximum/peak plasma drug concentration after drug administration)=amount × volume | The PK analysis set consisted of all patients from FAS who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | umol/L | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | PK Parameters: Tmax | The pharmacokinetic parameter, Tmax, may be determined using non-compartmental method(s) for deferasirox and its iron complex. Tmax=time to reach maximum/peak concentration following drug administration. | The PK analysis set consisted of all patients from FAS who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | pre-dose (0 hour), and at 2, and 4 hours at Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics (PK) Deferasirox Concentrations | Blood samples for PK evaluation were collected for a sub-group of patients. The patient had to have been on treatment without dose adjustment or treatment interruption (for any reason) for at least 4 consecutive days prior to scheduled PK sampling visit. If there was a dosage change or interruption within 4 days of the visit, no PK blood samples was collected, and an appropriate comment had to be made on the PK CRF page. | The PK analysis set consisted of all patients from FAS who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*umol/L | Weeks 12 & 24: pre-dose (0hr), 2hr & 4hr post-dose |
|
|
Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 63.2 months.
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 7 years.
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 | Chinese | This group was comprised of Chinese participants only | 2 | 68 | 15 | 68 | 26 | 68 |
| EG001 | Non-Chinese | This group was comprised of non- Chinese participants only | 0 | 66 | 30 | 66 | 58 | 66 |
| EG002 | All Patients | This group was comprised of all patients: Chinese and non-Chinese participants | 2 | 134 | 45 | 134 | 84 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Extramedullary haemopoiesis | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Superior mesenteric artery syndrome | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 4, 2014 | Jul 17, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 50 - < 65 years |
|
| Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|