| Primary | Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment | Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2* evaluations may predict cardiac events, e.g., impaired (<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2*: found in 62% of patients with T2*<8 ms; 20% with T2* of 8-12 ms; and in 5% with T2* >12 ms (Tanner 2006) | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations. | Posted | | Geometric Mean | 95% Confidence Interval | Millisecond | | 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL) | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months. | | OG001 | Core: Deferoxamine (DFO) | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.12± 3.687(1.07 to 1.18)
- OG0011.07± 2.931(1.02 to 1.11)
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| Secondary | Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate. | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations. | Posted | | Least Squares Mean | Standard Error | Percent | | 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Mean | Standard Deviation | Percent | | 6 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week |
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| Secondary | Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment | Summary statistics of T2* ratio Month 6/baseline | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | 6 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI) | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Mean | Standard Deviation | Milliliter | | 6 Month, 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) | An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Mean | Standard Deviation | Percent | | 6 Month, 12 Month | | | | ID | Title | Description |
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| OG000 | Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week |
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| Secondary | Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI) | An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Mean | Standard Deviation | gram/m^2 | | 6 Month, 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine | The number of patients withdrawn from the study due to LVEF <50%, T2* <6 ms or significant decreases in T2* ≥ 33% from baseline was provided per treatment group. | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Posted | | Number | | Participants | | 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month | | OG001 | Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. | Number of patients with adverse events, serious adverse events and death | Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered | Posted | | Number | | Participants | | 12 Month | | | | ID | Title | Description |
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| OG000 | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month |
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| Secondary | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau) | The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau) | Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose). | Posted | | Mean | Standard Deviation | (h.ng/mL) | | 12 Month | | | | ID | Title | Description |
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| OG000 | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day |
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| Secondary | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax) | The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, maximum plasma concentration (Cmax) | Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose). | Posted | | Mean | Standard Deviation | umol/L | | 12 Month | | | | ID | Title | Description |
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| OG000 | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day |
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| Secondary | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data | The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. For trough concentration assessments, a 2-mL blood sample was to be taken on arrival at the study site, i.e. prior to the patient receiving the daily deferasirox dose (pre-dose blood sample). A second 2-mL blood sample was to be taken 2 hours later (post-dose sample). At all other visits (Visits 3 - 14), a pre-dose sample was to be taken. For PK profile assessments, 3 blood samples were taken after 1, 2, and 4 hours post-dose in addition to the 2-mL pre-dose | Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose). | Posted | | Mean | Standard Deviation | (umol/L) | | Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day |
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| Secondary | Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment | The measured T2* values, the ratio (post-baseline / baseline T2*) at Month 6, 12, 18 and 24 was summarized for FAS population along with two-sided 95% CIs. The geometric means of the ratio was presented for all treatment groups | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension : ICL to ICL | Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension; DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) | |
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| Secondary | Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF) | Cardiac function endpoints (LVEF) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites. | Posted | | Mean | Standard Deviation | Percent | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) |
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| Secondary | Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | Cardiac function endpoints (LVESVI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites. | Posted | | Mean | Standard Deviation | mL/m^2 | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) |
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| Secondary | Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) | Cardiac function endpoint (LVEDVI ) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites | Posted | | Mean | Standard Deviation | mL/m^2 | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) |
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| Secondary | Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI) | Cardiac function endpoints (LVMI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites | Posted | | Mean | Standard Deviation | gram/m^2 | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) |
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| Secondary | Extension Study: The Cardiac Iron Concentration From T2* Values | Cardiac iron concentration (derived from T2* values) at baseline, Months 6, 12, 18 and 24 were summarized by descriptive statistics. The absolute change from baseline at Months 6, 12, 18 and 24 were also summarized by treatment group. Lliver iron concentration is expressed in units (mg of iron / g of liver tissue dry weight (dw) | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase | Posted | | Mean | Standard Deviation | mg Fe/g dw | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) |
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| Secondary | Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 | Results of liver iron content (LIC) measurements by MRI was summarized by descriptive statistics. The absolute value and the absolute change from baseline in LIC at Months 6, 12, 18 and 24 were provided by treatment group. | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase | Posted | | Mean | Standard Deviation | mg Fe/g dw | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) | | OG003 |
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| Secondary | Extension Study: Change in Serum Ferritin From Baseline by Month | Serum ferritin values was summarized by descriptive statistics. Absolute value and the absolute change from baseline in serum ferritin by month was provided by treatment group. | Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase | Posted | | Mean | Standard Deviation | ug/L | | Months 6, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Extension: ICL to ICL | Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day | | OG001 | Extension: DFO to DFO | Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week | | OG002 | Extension: DFO to ICL | DFO to ICL" (patients who switched from DFO to deferasirox in extension) | | OG003 | Extension: ICL to DFO |
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| Secondary | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax) | The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, time to reach maximum plasma concentration (Tmax) | Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose). | Posted | | Median | Inter-Quartile Range | (h) | | 12 Month | | | | ID | Title | Description |
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| OG000 | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day |
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