| Secondary | Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 24 | LIC was measured by magnetic resonance imaging technique at baseline and Week 24. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 24 with treatment as factor and baseline LIC as covariate. | Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24. Only patients with both baseline and at least one post-baseline value were included for this analysis. | Posted | | Least Squares Mean | Standard Error | mg iron (Fe)/g dry weight (dw) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG000-0.87± 0.448
- OG001-0.90± 0.450
- OG002-0.24± 0.439
|
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| Secondary | Core Study: Change in Serum Ferritin Between Baseline and Fourth Quarter | Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug. Fourth quarter serum ferritin average was the average of all serum ferritin values obtained within days 286- End of Study. Change from baseline: fourth quarter serum ferritin average - baseline serum ferritin average. | Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the fourth quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline. | Posted | | Mean | Standard Deviation | μg/L | | Baseline, (Day 286 to End of Study [Day 365]) | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Change in Serum Ferritin Between Baseline and Second Quarter | Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug. Second quarter serum ferritin average was the average of all serum ferritin values obtained within days 106-195. Change from baseline: second quarter serum ferritin average - baseline serum ferritin average. | Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the second quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline. | Posted | | Mean | Standard Deviation | μg/L | | Baseline, (Day 106 to Day 195) | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Percentage of Participants With Adverse Events Graded Mild, Moderate and Severe | Percentage of Participants with Mild, Moderate and Severe adverse events (AE) any primary system organ class regardless of study drug relationship. A patient with multiple occurrences of an AE is counted only once in the AE category for that treatment. A patient with multiple severity ratings for an AE while on a treatment is only counted once under the maximum rating. | Safety Analysis Set included all randomized participants who received treatment. | Posted | | Number | | Percentage of participants | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo |
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| Secondary | Core Study: Change in Liver Iron Concentration (LIC) From Baseline At Week 24 and Week 52 in Patients With Dose Increases After Week 24 | LIC was measured by magnetic resonance imaging technique at baseline, Week 24 and Week 52. Dose Doubling (Dose Increases) began at Week 24. | Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24 and Week 52. Only patients with dose increases after week 24, with both baseline and at least one post-baseline value were included for this analysis. | Posted | | Mean | Standard Deviation | mg iron (Fe)/g dry weight (dw) | | Baseline, Week 24, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 |
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| Secondary | Core Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration) | The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for the following cases:
- Baseline serum ferritin versus baseline LIC
- Serum ferritin difference from baseline at fourth quarter versus difference from baseline in LIC at Week 52.
A value of 1.0 indicates a perfect correlation. | Participants from the Full Analysis Set (all randomized participants). | Posted | | Number | | Correlation coefficient | | Baseline, 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | All Randomized Participants | Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Change From Baseline in Hemoglobin at Month 12 | Blood was collected for Hemoglobin at baseline and Month 12. Change from baseline= Month 12 hemoglobin - baseline hemoglobin. | Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Change From Baseline in Transferrin Saturation at Month 12 | Blood was collected for transferrin saturation at Baseline and Month 12. Change from baseline= Month 12 transferrin saturation - baseline transferrin saturation. | Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses. | Posted | | Mean | Standard Deviation | Percent saturation | | Baseline, Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Change in Liver Iron Concentration (LIC) in Placebo Patients From Baseline to Week 52 | LIC was measured by magnetic resonance imaging technique at baseline and Week 52. The change in liver iron concentration for participants in the placebo arm was used to assess the iron accumulation rate. | Safety Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis. | Posted | | Mean | Standard Deviation | mg iron (Fe)/g dry weight (dw) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Core Study: Percentage of Participants With Notable Abnormal Post-baseline Laboratory Results | The percentage of participants with notable laboratory results: Platelet count: (<100 x 10^9/L) Absolute neutrophils: (<1.5 x 10^9/L) Alanine aminotransferase (ALT): (>5 x Upper limit normal (ULN) and >2 x baseline). Aspartate aminotransferase (AST): (>5 x ULN and >2 x baseline) Serum creatinine: (>33% increase from baseline and >ULN at ≥2 consecutive post-baseline values) Creatinine clearance: (<60 mL/min at ≥2 consecutive post-baseline values) Urinary protein/creatinine ratio: (≥ 1.0 mg/mg at ≥2 consecutive post-baseline values) | Safety Set included all randomized participants who received treatment. | Posted | | Number | | Percentage of participants | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
|
| Primary | Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52 | LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate. | Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis. | Posted | | Least Squares Mean | Standard Error | mg iron (Fe)/g dry weight (dw) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 |
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| Secondary | Core Study: Percentage of Participants With Notably Abnormal Post-baseline Systolic Blood Pressure | Systolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes. A Notably Abnormal Systolic Blood Pressure was defined as a measurement in one of the following two categories: High: ≥180 with an increase from baseline ≥20 mmHg Low: ≤90 with a decrease from baseline ≥20 mmHg | Safety Set includes all randomized participants who received treatment. | Posted | | Number | | Percentage of participants | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo |
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| Secondary | Core Study: Percentage of Participants With Notably Abnormal Post-baseline Diastolic Blood Pressure | Diastolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes. A Notably Abnormal Diastolic Blood Pressure was defined as a measurement in one of the following two categories: High: ≥105 with an increase from baseline ≥15 mmHg Low: ≤50 with a decrease from baseline ≥15 mmHg | Safety Set includes all randomized participants who received treatment. | Posted | | Number | | Percentage of participants | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo |
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| Secondary | Core Study: Percentage of Participants With Notably Abnormal Post-baseline Pulse Rate | Pulse Rate was measured at each visit. A Notably Abnormal Pulse Rate was defined as a measurement in one of the following two categories: High: ≥120 with an increase from baseline ≥15 beats per minute (bpm) Low: ≤50 with a decrease from baseline ≥15 bpm | Safety Set includes all randomized participants who received treatment. | Posted | | Number | | Percentage of participants | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 5 mg/kg/Day Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG001 | 10 mg/kg/Day Deferasirox | Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. | | OG002 | Placebo | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Extension Study: Absolute Change in Serum Ferritin From Baseline to Eighth Quarter | Blood was collected for serum ferritin at Core Baseline and monthly during the Eighth quarter of the Extension Study. Absolute change from Baseline: quarterly average - baseline average. A negative change from baseline indicated improvement. | Full Analysis Set included all randomized participants. Only patients with a value both at baseline and at considered time point are included. | Posted | | Mean | Standard Deviation | micrograms/liter | | Core Baseline, Eighth Quarter (last 3 months of the study) | | | | ID | Title | Description |
|---|
| OG000 | Deferasirox | Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. | | OG001 | Placebo/Deferasirox | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. |
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| Primary | Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study | Liver iron concentration was measured at Core Baseline and at the end of the Extension Study. Magnetic Resonance Imaging (MRI) scans were analyzed at a central laboratory to determine the LIC value. The percentage of participants with LIC < 5 mgFe/g dw (milligram iron/gram dry weight) change from Baseline at the end of the Extension Study is reported. | Full Analysis consisted of all randomized participants. Patients with post-baseline LIC satisfying criterion at any time during the study are counted as responder. Patients with no baseline LIC or without any post-baseline LIC measurements will be assumed as non-responder. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Core Baseline to End of Extension Study (up to 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Deferasirox | Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. | | OG001 | Placebo/Deferasirox | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. |
|
| Secondary | Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 | LIC was measured by magnetic resonance imaging technique at Baseline and Month 24. A negative change from baseline indicated improvement. | Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis. | Posted | | Mean | Standard Deviation | mg iron (Fe)/g dry weight (dw) | | Core Baseline, Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Deferasirox | Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. | | OG001 | Placebo/Deferasirox | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. |
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| Secondary | Extension Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration) | The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for serum ferritin difference from Baseline at Month 24 versus LIC difference from Baseline at Month 24. A value of 1.0 indicates a perfect correlation. | Participants from the Extension Full Analysis Set (all randomized participants)in the Extension Study with data available for analysis. | Posted | | Number | | Correlation coefficient | | Core Baseline, Month 24 | | | | ID | Title | Description |
|---|
| OG000 | All Randomized Participants | Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. |
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| Secondary | Extension Study: Change From Baseline in Hemoglobin at Month 24 | Blood was collected for Hemoglobin at Baseline and Month 24. Change from Baseline= Month 24 hemoglobin - Baseline hemoglobin. | Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses. | Posted | | Mean | 95% Confidence Interval | g/L | | Core Baseline, Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. | | OG001 | Placebo/Deferasirox | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. |
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| Secondary | Extension Study: Change From Baseline in Transferrin Saturation at Month 24 | Blood was collected for transferrin saturation at Baseline and Month 24. Change from baseline= Month 24 transferrin saturation - baseline transferrin saturation. | Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses. | Posted | | Mean | 95% Confidence Interval | Percent saturation | | Core Baseline, Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Deferasirox | Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. | | OG001 | Placebo/Deferasirox | Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. |
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