Trial Outcomes & Findings for Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload (NCT NCT00600938)

NCT ID: NCT00600938

Last Updated: 2014-08-27

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 197 participants
• Primary outcome timeframe: 12 Month
• Results posted on: 2014-08-27

Participant Flow

Patients randomized to 1 of 2 treatment grps ICL or DFO, 20 mg/kg/day once daily for 2 wks, followed by 30 mg/kg/day od for 1 wk and 40 mg/kg/day od (DFO) target dose of 50 to 60 mg/kg/day 8 to 12 hour for 5 to 7 days/wk. In ext. pts could either stay in the same grp from core or could switch grps: ICL to ICL, DFO to DFO, DFO to ICL and ICL to DFO

Participant milestones

Measure	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	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	DFO to ICL (Deferoxamine to Deferasirox) DFO to ICL" (patients who switched from DFO to deferasirox in extension)	ICL to DFO (Deferasirox to Deferoxamine) ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study STARTED	98	99	0	0
Core Study Core Safety Set	96	91	0	0
Core Study Per Protocol Set (PPS)	91	81	0	0
Core Study COMPLETED	82	78	0	0
Core Study NOT COMPLETED	16	21	0	0
Extension Study STARTED	74	29	42	1
Extension Study Extension Safety Set	73	29	42	1
Extension Study COMPLETED	65	24	33	0
Extension Study NOT COMPLETED	9	5	9	1

Reasons for withdrawal

Measure	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	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	DFO to ICL (Deferoxamine to Deferasirox) DFO to ICL" (patients who switched from DFO to deferasirox in extension)	ICL to DFO (Deferasirox to Deferoxamine) ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study Abnormal test procedure result(s)	3	2	0	0
Core Study Unsatisfactory therapeutic effect	1	2	0	0
Core Study Patient withdrew consent	7	12	0	0
Core Study Lost to Follow-up	3	2	0	0
Core Study Death	1	1	0	0
Core Study Protocol Violation	1	2	0	0
Extension Study Adverse Event	1	0	2	0
Extension Study Abnormal test procedure results	0	1	1	1
Extension Study Unsatisfactory therapeutic effect	4	1	1	0
Extension Study Withdrawal by Subject	2	2	3	0
Extension Study Lost to Follow-up	1	1	2	0
Extension Study Death	1	0	0	0

Baseline Characteristics

Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload

Baseline characteristics by cohort

Measure	Core: Deferasirox (ICL) n=98 Participants 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	Core: Deferoxamine (DFO) n=99 Participants 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week	Total n=197 Participants Total of all reporting groups
Age, Continuous	19.9 Years STANDARD_DEVIATION 6.53 • n=5 Participants	19.7 Years STANDARD_DEVIATION 6.32 • n=7 Participants	19.8 Years STANDARD_DEVIATION 6.41 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	57 Participants n=7 Participants	115 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Month

Population: 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.

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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=91 Participants 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.	Core: Deferoxamine (DFO) n=81 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment	1.12 Millisecond 95% Confidence Interval 3.687 • Interval 1.07 to 1.18	1.07 Millisecond 95% Confidence Interval 2.931 • Interval 1.02 to 1.11	—	—

SECONDARY outcome

Timeframe: 12 Month

Population: 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.

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.

Outcome measures

Measure	Core: Deferasirox (ICL) n=91 Participants 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.	Core: Deferoxamine (DFO) n=81 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)	-0.5 Percent Standard Error 0.47 • Interval 1.07 to 1.18	-0.0 Percent Standard Error 0.49 • Interval 1.02 to 1.11	—	—

SECONDARY outcome

Timeframe: 6 Month

Population: 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

An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized

Outcome measures

Measure	Core: Deferasirox (ICL) n=85 Participants 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.	Core: Deferoxamine (DFO) n=73 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)	-0.95 Percent Standard Deviation 4.485	-0.37 Percent Standard Deviation 4.389	—	—

SECONDARY outcome

Timeframe: 6 Month

Population: 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

Summary statistics of T2* ratio Month 6/baseline

Outcome measures

Measure	Core: Deferasirox (ICL) n=85 Participants 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.	Core: Deferoxamine (DFO) n=73 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment	1.04 Ratio 95% Confidence Interval 4.752 • Interval 1.0 to 1.08	1.04 Ratio 95% Confidence Interval 4.417 • Interval 1.0 to 1.08	—	—

SECONDARY outcome

Timeframe: 6 Month, 12 Month

Population: 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

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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=91 Participants 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.	Core: Deferoxamine (DFO) n=81 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Change from baseline at 6 Month (n= 85, 73)	1.8 Milliliter Standard Deviation 8.021	0.88 Milliliter Standard Deviation 8.919	—	—
Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Change from Baseline at 12 Month/EOS (n= 91, 81)	1.57 Milliliter Standard Deviation 8.040	0.10 Milliliter Standard Deviation 10.387	—	—

SECONDARY outcome

Timeframe: 6 Month, 12 Month

Population: 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

An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized

Outcome measures

Measure	Core: Deferasirox (ICL) n=91 Participants 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.	Core: Deferoxamine (DFO) n=81 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
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) Change from Baseline at 6 Month (n= 85, 73)	1.81 Percent Standard Deviation 14.515	1.48 Percent Standard Deviation 19.188	—	—
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) Change from Baseline at 12 Month/EOS (n= 91, 81)	1.79 Percent Standard Deviation 13.122	1.10 Percent Standard Deviation 20.485	—	—

SECONDARY outcome

Timeframe: 6 Month, 12 Month

Population: 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

An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized

Outcome measures

Measure	Core: Deferasirox (ICL) n=91 Participants 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.	Core: Deferoxamine (DFO) n=81 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI) Change from Baseline at 12 Month/EOS (n= 91, 81)	4.13 gram/m^2 Standard Deviation 15.055	5.25 gram/m^2 Standard Deviation 14.973	—	—
Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI) Change from Baseline at 6 Month (n= 85, 73)	1.01 gram/m^2 Standard Deviation 13.102	3.32 gram/m^2 Standard Deviation 13.585	—	—

SECONDARY outcome

Timeframe: 12 Month

Population: 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

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.

Outcome measures

Measure	Core: Deferasirox (ICL) n=98 Participants 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.	Core: Deferoxamine (DFO) n=99 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine	3 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 12 Month

Population: 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

Number of patients with adverse events, serious adverse events and death

Outcome measures

Measure	Core: Deferasirox (ICL) n=96 Participants 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.	Core: Deferoxamine (DFO) n=91 Participants 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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. Death. None were considered related to study drug.	1 Participants	1 Participants	—	—
Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. At least one AE	65 Participants	69 Participants	—	—
Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. Serious Adverse Events	10 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: 12 Month

Population: 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).

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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=13 Participants 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.	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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)	2129.70 (h.ng/mL) Standard Deviation 930.202	—	—	—

SECONDARY outcome

Timeframe: 12 Month

Population: 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).

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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=13 Participants 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.	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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)	150.09 umol/L Standard Deviation 59.143	—	—	—

SECONDARY outcome

Timeframe: Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose)

Population: 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).

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=13 Participants 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.	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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 1, 0 hour (predose)	32.25 (umol/L) Standard Deviation 21.288 • Interval 1.0 to 4.0	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 1, 1 hour (post dos)	96.32 (umol/L) Standard Deviation 35.799	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 1, 2 hour (post dose)	136.47 (umol/L) Standard Deviation 51.831	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 1, 4 hour (post dose)	133.33 (umol/L) Standard Deviation 62.815	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 2, 0 hour (predose)	38.66 (umol/L) Standard Deviation 29.887	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 2, 1 hour (post dose)	119.48 (umol/L) Standard Deviation 38.709	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 2, 2 hour (post dose)	177.19 (umol/L) Standard Deviation 55.343	—	—	—
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data Month 2, 4 hour (post dose)	180.76 (umol/L) Standard Deviation 57.877	—	—	—

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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.

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment Month 6 (n=71,26,40,1)	1.06 Ratio 95% Confidence Interval 2.763 • Interval 1.01 to 1.11	1.05 Ratio 95% Confidence Interval 2.024 • Interval 0.98 to 1.12	1.03 Ratio 95% Confidence Interval 2.778 • Interval 0.98 to 1.09	1.00 Ratio 95% Confidence Interval 0 95CI is not available for ICL to DFO group as there is only 1 patient.
Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment Month 12(n=66, 29, 41, 1)	1.17 Ratio 95% Confidence Interval 3.654 • Interval 1.11 to 1.24	1.06 Ratio 95% Confidence Interval 2.680 • Interval 0.97 to 1.15	1.07 Ratio 95% Confidence Interval 3.411 • Interval 1.01 to 1.14	1.17 Ratio 95% Confidence Interval 0 95CI is not available for ICL to DFO group as there is only 1 patient.
Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment Month 18 (n=68, 26, 39, 1)	1.24 Ratio 95% Confidence Interval 5.112 • Interval 1.16 to 1.34	1.18 Ratio 95% Confidence Interval 3.748 • Interval 1.05 to 1.32	1.13 Ratio 95% Confidence Interval 4.376 • Interval 1.04 to 1.23	1.05 Ratio 95% Confidence Interval 0 95CI is not available for ICL to DFO group as there is only 1 patient.
Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment Month 24 (n=63, 25, 33, 1)	1.38 Ratio 95% Confidence Interval 5.277 • Interval 1.28 to 1.49	1.33 Ratio 95% Confidence Interval 5.821 • Interval 1.13 to 1.55	1.21 Ratio 95% Confidence Interval 4.658 • Interval 1.09 to 1.34	1.11 Ratio 95% Confidence Interval 0 95CI is not available for ICL to DFO group as there is only 1 patient.

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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.

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF) Month 6 (n=71,26,40,1)	-1.1 Percent Standard Deviation 4.96	-1.8 Percent Standard Deviation 3.59	0.1 Percent Standard Deviation 4.60	-1.0 Percent Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF) Month 12 (n= 66,29,42,1)	-0.5 Percent Standard Deviation 5.02	0.3 Percent Standard Deviation 5.13	0.0 Percent Standard Deviation 3.73	0 Percent Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF) Month 18 (n=68,26,39,1 )	-0.1 Percent Standard Deviation 4.84	-0.8 Percent Standard Deviation 5.14	-1.3 Percent Standard Deviation 3.74	-10.0 Percent Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF) Month 24 (n= 63,25,33,1)	0.6 Percent Standard Deviation 4.72	-0.6 Percent Standard Deviation 5.02	0.2 Percent Standard Deviation 4.82	-18.0 Percent Standard Deviation 0

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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.

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Month 6 (n=69,26,40,1)	1.7 mL/m^2 Standard Deviation 7.98	3.4 mL/m^2 Standard Deviation 10.40	0 mL/m^2 Standard Deviation 8.22	1 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Month 12 (n=64,28,40,1 )	1.5 mL/m^2 Standard Deviation 7.42	-0.8 mL/m^2 Standard Deviation 9.74	0.6 mL/m^2 Standard Deviation 9.69	2 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Month 18 (n=67,24,35,1 )	2.4 mL/m^2 Standard Deviation 10.58	2.8 mL/m^2 Standard Deviation 11.54	4.1 mL/m^2 Standard Deviation 6.88	28.0 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI) Month 24 (n=60,23,33,0 )	1.6 mL/m^2 Standard Deviation 10.21	4.3 mL/m^2 Standard Deviation 8.66	1.7 mL/m^2 Standard Deviation 8.56	NA mL/m^2 Standard Deviation NA no participant analyzed

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) Month 6 (n=69,26,40,1)	2.0 mL/m^2 Standard Deviation 14.19	3.5 mL/m^2 Standard Deviation 21.95	0.5 mL/m^2 Standard Deviation 18.77	1.0 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) Month 12 (n=64,28,40,1)	2.0 mL/m^2 Standard Deviation 13.49	-0.6 mL/m^2 Standard Deviation 18.56	3.0 mL/m^2 Standard Deviation 23.06	4.0 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) Month 18 (n=67,24,35,1)	6.5 mL/m^2 Standard Deviation 17.80	4.2 mL/m^2 Standard Deviation 19.75	8.3 mL/m^2 Standard Deviation 16.08	36.0 mL/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) Month 24 (n=60,23,33,0)	3.4 mL/m^2 Standard Deviation 21.15	9.5 mL/m^2 Standard Deviation 14.60	5.4 mL/m^2 Standard Deviation 13.97	NA mL/m^2 Standard Deviation NA No participant analyzed

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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

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

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI) Month 6 (n=69,26,40,1)	1.4 gram/m^2 Standard Deviation 12.37	1.8 gram/m^2 Standard Deviation 15.98	3.2 gram/m^2 Standard Deviation 13.38	-6.0 gram/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI) Month 12 (n=64,28,40,1)	4.2 gram/m^2 Standard Deviation 13.90	9.1 gram/m^2 Standard Deviation 14.19	3.4 gram/m^2 Standard Deviation 16.54	1 gram/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI) Month 18 (n=67,24,35,1)	4.8 gram/m^2 Standard Deviation 14.37	-0.1 gram/m^2 Standard Deviation 16.87	4.0 gram/m^2 Standard Deviation 14.39	37.0 gram/m^2 Standard Deviation 0
Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI) Month 24 (n=60,23,33,0)	5.6 gram/m^2 Standard Deviation 13.00	6.7 gram/m^2 Standard Deviation 14.96	10.3 gram/m^2 Standard Deviation 13.32	NA gram/m^2 Standard Deviation NA No participant analyzed

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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 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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=26 Participants 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.	Extension; DFO to ICL n=40 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: The Cardiac Iron Concentration From T2* Values Month 6 (n=71,26,40,1)	-0.12 mg Fe/g dw Standard Deviation 0.587	-0.12 mg Fe/g dw Standard Deviation 0.539	-0.08 mg Fe/g dw Standard Deviation 0.465	0 mg Fe/g dw Standard Deviation 0
Extension Study: The Cardiac Iron Concentration From T2* Values Month 12 (n=66,29,41,1)	-0.38 mg Fe/g dw Standard Deviation 0.674	-0.12 mg Fe/g dw Standard Deviation 0.695	-0.14 mg Fe/g dw Standard Deviation 0.490	-0.77 mg Fe/g dw Standard Deviation 0
Extension Study: The Cardiac Iron Concentration From T2* Values Month 18 (n=68,26,39,1)	-0.47 mg Fe/g dw Standard Deviation 0.789	-0.45 mg Fe/g dw Standard Deviation 0.797	-0.20 mg Fe/g dw Standard Deviation 0.607	-0.24 mg Fe/g dw Standard Deviation 0
Extension Study: The Cardiac Iron Concentration From T2* Values Month 24 (n=63,25,33,1)	-0.70 mg Fe/g dw Standard Deviation 0.834	-0.69 mg Fe/g dw Standard Deviation 0.989	-0.34 mg Fe/g dw Standard Deviation 0.863	-0.52 mg Fe/g dw Standard Deviation 0

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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

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.

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 Month 18 (n=70,23,38,1)	-12.26 mg Fe/g dw Standard Deviation 13.938	-26.09 mg Fe/g dw Standard Deviation 13.443	-10.87 mg Fe/g dw Standard Deviation 11.116	-2.90 mg Fe/g dw Standard Deviation 0
Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 Month 24 (n=60,24,33,1)	-15.74 mg Fe/g dw Standard Deviation 15.205	-26.02 mg Fe/g dw Standard Deviation 14.867	-10.96 mg Fe/g dw Standard Deviation 11.070	-3.20 mg Fe/g dw Standard Deviation 0
Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 Month 6 (n=71,26,38,1)	-4.56 mg Fe/g dw Standard Deviation 7.467	-12.66 mg Fe/g dw Standard Deviation 7.821	-6.30 mg Fe/g dw Standard Deviation 7.375	-3.80 mg Fe/g dw Standard Deviation 0
Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24 Month 12 (n=69,29,40,1)	-10.22 mg Fe/g dw Standard Deviation 10.674	-19.44 mg Fe/g dw Standard Deviation 11.446	-7.98 mg Fe/g dw Standard Deviation 9.310	-3.90 mg Fe/g dw Standard Deviation 0

SECONDARY outcome

Timeframe: Months 6, 12, 18 and 24

Population: 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

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.

Outcome measures

Measure	Core: Deferasirox (ICL) n=74 Participants 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.	Core: Deferoxamine (DFO) n=29 Participants 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.	Extension; DFO to ICL n=42 Participants DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO n=1 Participants ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension Study: Change in Serum Ferritin From Baseline by Month Month 12 (n=70,29,40,1)	-988.46 ug/L Standard Deviation 2883.416	-1877.00 ug/L Standard Deviation 1877.745	-1223.73 ug/L Standard Deviation 1808.056	-498.00 ug/L Standard Deviation 0
Extension Study: Change in Serum Ferritin From Baseline by Month Month 18 (n=66,24,39,1)	-1962.14 ug/L Standard Deviation 2225.438	-2426.92 ug/L Standard Deviation 2685.817	-1494.82 ug/L Standard Deviation 1511.257	-1067.00 ug/L Standard Deviation 0
Extension Study: Change in Serum Ferritin From Baseline by Month Month 6 (n=72,28,38,0)	-626.10 ug/L Standard Deviation 1541.406	-1307.14 ug/L Standard Deviation 1520.877	-1054.87 ug/L Standard Deviation 1967.651	NA ug/L Standard Deviation NA No participants analyzed
Extension Study: Change in Serum Ferritin From Baseline by Month Month 24 (n=59,24,30,0)	-2239.03 ug/L Standard Deviation 2178.564	-2724.00 ug/L Standard Deviation 2693.583	-1513.23 ug/L Standard Deviation 2278.144	NA ug/L Standard Deviation NA No participants analyzed

SECONDARY outcome

Timeframe: 12 Month

Population: 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).

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)

Outcome measures

Measure	Core: Deferasirox (ICL) n=13 Participants 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.	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.	Extension; DFO to ICL DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension: ICL to DFO ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)	4.00 (h) Inter-Quartile Range 930.202 • Interval 1.0 to 4.0	—	—	—

Adverse Events

Core Phase - ICL670

Serious events: 10 serious events

Other events: 60 other events

Deaths: 0 deaths

Core Phase - DFO

Serious events: 10 serious events

Other events: 58 other events

Deaths: 0 deaths

Extension Phase - ICL to ICL

Serious events: 14 serious events

Other events: 56 other events

Deaths: 0 deaths

Extension Phase - DFO to DFO

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Extension Phase - DFO to ICL

Serious events: 9 serious events

Other events: 36 other events

Deaths: 0 deaths

Extension Phase - ICL to DFO

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Core Phase - ICL670 n=96 participants at risk 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	Core Phase - DFO n=91 participants at risk 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	Extension Phase - ICL to ICL n=73 participants at risk 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	Extension Phase - DFO to DFO n=29 participants at risk 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	Extension Phase - DFO to ICL n=42 participants at risk DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension Phase - ICL to DFO n=1 participants at risk ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Blood and lymphatic system disorders Hypersplenism	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Blood and lymphatic system disorders Neutropenia	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Cardiac disorders Arrhythmia	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Endocrine disorders Hypogonadism	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Abdominal pain upper	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Colitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Diarrhoea	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Dyspepsia	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Gastric haemorrhage	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Gastritis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Ileus	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Oesophageal rupture	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Vomiting	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Face oedema	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Local swelling	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Pyrexia	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Hepatobiliary disorders Cholecystitis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Hepatobiliary disorders Cholelithiasis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Abdominal abscess	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Acute tonsillitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Amoebiasis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Anal abscess	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Appendicitis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Bronchitis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Bronchopneumonia	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Gastroenteritis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Gastrointestinal infection	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Herpes zoster	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Influenza	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Liver abscess	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Meningitis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Pneumonia	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Tooth infection	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Urinary tract infection	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Wound infection	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Yersinia infection	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Injury, poisoning and procedural complications Radius fracture	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Calcium deficiency	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Haemosiderosis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.7% 2/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Iron overload	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.7% 2/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Musculoskeletal and connective tissue disorders Back pain	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Nervous system disorders Grand mal convulsion	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase

Other adverse events

Measure	Core Phase - ICL670 n=96 participants at risk 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	Core Phase - DFO n=91 participants at risk 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	Extension Phase - ICL to ICL n=73 participants at risk 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	Extension Phase - DFO to DFO n=29 participants at risk 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	Extension Phase - DFO to ICL n=42 participants at risk DFO to ICL" (patients who switched from DFO to deferasirox in extension)	Extension Phase - ICL to DFO n=1 participants at risk ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.9% 2/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Endocrine disorders Hypogonadism	2.1% 2/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Eye disorders Conjunctivitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Abdominal pain	7.3% 7/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.6% 7/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Abdominal pain upper	5.2% 5/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 5/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.2% 6/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	10.3% 3/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	11.9% 5/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Diarrhoea	12.5% 12/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	13.7% 10/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	21.4% 9/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Nausea	6.2% 6/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.5% 4/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Gastrointestinal disorders Vomiting	6.2% 6/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.2% 6/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.5% 4/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Fatigue	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Injection site reaction	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
General disorders Pyrexia	5.2% 5/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 5/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.2% 6/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	10.3% 3/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	11.9% 5/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Acute tonsillitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Bronchitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Influenza	10.4% 10/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.6% 6/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	15.1% 11/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	16.7% 7/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Nasopharyngitis	8.3% 8/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	16.4% 12/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	14.3% 6/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Otitis media	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Pharyngitis	3.1% 3/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Tonsillitis	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Upper respiratory tract infection	8.3% 8/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.8% 8/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	17.8% 13/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	21.4% 9/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Infections and infestations Urinary tract infection	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.5% 4/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Alanine aminotransferase increased	9.4% 9/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 5/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	12.3% 9/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.9% 2/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.5% 4/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Aspartate aminotransferase increased	7.3% 7/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	11.0% 8/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Blood creatinine increased	8.3% 8/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	12.3% 9/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Ejection fraction decreased	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Electrocardiogram QT prolonged	0.00% 0/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Platelet count increased	2.1% 2/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 5/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.1% 3/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	20.7% 6/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Investigations Protein urine present	11.5% 11/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.8% 8/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.2% 6/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	16.7% 7/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Metabolism and nutrition disorders Diabetes mellitus	3.1% 3/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.8% 5/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 7/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.8% 5/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.9% 2/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Musculoskeletal and connective tissue disorders Back pain	7.3% 7/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.4% 4/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.6% 7/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Musculoskeletal and connective tissue disorders Osteoporosis	5.2% 5/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.1% 3/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.4% 1/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Nervous system disorders Headache	5.2% 5/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 5/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.6% 7/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.9% 2/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	9.5% 4/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Psychiatric disorders Depression	2.1% 2/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Cough	4.2% 4/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	6.8% 5/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 4/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.0% 1/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.1% 1/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	1.4% 1/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	7.1% 3/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 6/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.2% 2/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	8.2% 6/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	11.9% 5/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	100.0% 1/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Skin and subcutaneous tissue disorders Rash	4.2% 4/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	2.4% 1/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase
Skin and subcutaneous tissue disorders Urticaria	3.1% 3/96 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	3.3% 3/91 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	5.5% 4/73 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	10.3% 3/29 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	4.8% 2/42 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase	0.00% 0/1 Core : The safety set consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline. safety assessment. Extension: one patient assigned to the deferasirox arm died before receiving treatment in the extension phase

Additional Information

Study Director

Novartis Pharnaceuticals

Phone: 862-778-8300

Email: trialandresults.registries@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
• Publication restrictions are in place

Restriction type: OTHER