Table 1

Baseline patient characteristics

VariableDeferasirox (n = 98)DFO (n = 99)All patients (n = 197)
β-thalassemia major, n (%) 98 (100) 99 (100) 197 (100) 
Age, y 19.9 ± 6.5 19.7 ± 6.3 19.8 ± 6.4 
Age range, y 10.0-39.0 10.0-40.0 10.0-40.0 
Male:female, n 58:40 57:42 115:82 
Race, n (%)    
 White 59 (60.2) 59 (59.6) 118 (59.9) 
 Black 0 (0.0) 0 (0.0) 0 (0.0) 
 Asian 38 (38.8) 40 (40.4) 78 (39.6) 
 Other 1 (1.0) 0 (0.0) 1 (0.5) 
Hepatitis status, n (%)    
 Hepatitis B 1 (1.0) 2 (2.0) 3 (1.5) 
 Hepatitis C 22 (22.4) 19 (19.2) 41 (20.8) 
 Hepatitis B and C 0 (0.0) 2 (2.0) 2 (1.0) 
 No hepatitis 75 (76.5) 80 (80.8) 155 (78.7) 
Time since start of blood transfusions, y 19.3 ± 6.4 18.4 ± 6.2 18.8 ± 6.3 
Total number of blood transfusions received 315.6 294.8 305.3 
Previous chelation therapy, n (%) 96 (100) 91 (100) 187 (100) 
 DFO 41 (42.7) 39 (42.9) 80 (42.8) 
 Deferiprone 9 (9.4) 5 (5.5) 14 (7.5) 
 DFO + deferiprone 21 (21.9) 21 (23.1) 42 (22.5) 
 Deferasirox 18 (18.8) 23 (25.3) 41 (21.9) 
 Other 7 (7.3) 3 (3.3) 10 (5.3) 
Time since start of first chelation therapy, y 14.0 ± 7.0 14.3 ± 7.2 14.2 ± 7.1 
Myocardial T2* categories, n (%)    
 6 to <10 ms 33 (33.7) 32 (32.3) 65 (33.0) 
 10 to ≤20 ms 65 (66.3) 67 (67.7) 132 (67.0) 
LVEF, n (%)    
 <LLN by Westwood§ 11 (12.1) 10 (12.3) 21 (12.2) 
 ≥LLN by Westwood§ 80 (87.9) 71 (87.7) 151 (87.8) 
 LIC, mg Fe/g dw 29.8 ± 17.5 30.3 ± 17.9 30.0 ± 17.7 
LIC categories, n (%)    
 LIC < 7 mg Fe/g dw 11 (12.1) 8 (9.9) 19 (11.0) 
 LIC 7 to <15 mg Fe/g dw 14 (15.4) 14 (17.3) 28 (16.3) 
 LIC ≥ 15 mg Fe/g dw 66 (72.5) 59 (72.8) 125 (72.7) 
Median serum ferritin (range), ng/mL 5062 (613-15 331) 4684 (677-13 342) 4878 (613-15 331) 
VariableDeferasirox (n = 98)DFO (n = 99)All patients (n = 197)
β-thalassemia major, n (%) 98 (100) 99 (100) 197 (100) 
Age, y 19.9 ± 6.5 19.7 ± 6.3 19.8 ± 6.4 
Age range, y 10.0-39.0 10.0-40.0 10.0-40.0 
Male:female, n 58:40 57:42 115:82 
Race, n (%)    
 White 59 (60.2) 59 (59.6) 118 (59.9) 
 Black 0 (0.0) 0 (0.0) 0 (0.0) 
 Asian 38 (38.8) 40 (40.4) 78 (39.6) 
 Other 1 (1.0) 0 (0.0) 1 (0.5) 
Hepatitis status, n (%)    
 Hepatitis B 1 (1.0) 2 (2.0) 3 (1.5) 
 Hepatitis C 22 (22.4) 19 (19.2) 41 (20.8) 
 Hepatitis B and C 0 (0.0) 2 (2.0) 2 (1.0) 
 No hepatitis 75 (76.5) 80 (80.8) 155 (78.7) 
Time since start of blood transfusions, y 19.3 ± 6.4 18.4 ± 6.2 18.8 ± 6.3 
Total number of blood transfusions received 315.6 294.8 305.3 
Previous chelation therapy, n (%) 96 (100) 91 (100) 187 (100) 
 DFO 41 (42.7) 39 (42.9) 80 (42.8) 
 Deferiprone 9 (9.4) 5 (5.5) 14 (7.5) 
 DFO + deferiprone 21 (21.9) 21 (23.1) 42 (22.5) 
 Deferasirox 18 (18.8) 23 (25.3) 41 (21.9) 
 Other 7 (7.3) 3 (3.3) 10 (5.3) 
Time since start of first chelation therapy, y 14.0 ± 7.0 14.3 ± 7.2 14.2 ± 7.1 
Myocardial T2* categories, n (%)    
 6 to <10 ms 33 (33.7) 32 (32.3) 65 (33.0) 
 10 to ≤20 ms 65 (66.3) 67 (67.7) 132 (67.0) 
LVEF, n (%)    
 <LLN by Westwood§ 11 (12.1) 10 (12.3) 21 (12.2) 
 ≥LLN by Westwood§ 80 (87.9) 71 (87.7) 151 (87.8) 
 LIC, mg Fe/g dw 29.8 ± 17.5 30.3 ± 17.9 30.0 ± 17.7 
LIC categories, n (%)    
 LIC < 7 mg Fe/g dw 11 (12.1) 8 (9.9) 19 (11.0) 
 LIC 7 to <15 mg Fe/g dw 14 (15.4) 14 (17.3) 28 (16.3) 
 LIC ≥ 15 mg Fe/g dw 66 (72.5) 59 (72.8) 125 (72.7) 
Median serum ferritin (range), ng/mL 5062 (613-15 331) 4684 (677-13 342) 4878 (613-15 331) 

Values are mean ± SD unless otherwise stated.

LLN, lower limit of normal.

Unknown, or patients received irregular deferiprone and/or DFO therapy.

Based on the per-protocol population.

§

Westwood criteria: LLN, 59 for males and 63 for females.34 

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