Table 1 Patient characteristics by randomization

From: Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia—a phase 3 study

Treatment arm All randomized and evaluable patients in the study
Standard S-HAM P
No. of patients, N (%) 184 (48) 203 (52)  
Age, years    0.722a
  Median (range) 58 (18–86) 58 (19–81)  
Sex    0.026b
 Female/male, N (%) 76/108 (41/59) 107/96 (53/47)  
Patient age (chronological), N (%)    0.760b
  <60 years 101 (55) 108 (53)  
  ≥60 years 83 (45) 95 (47)  
Patient age (biological), N (%)
  Younger: <60 (−70) 119 (65) 132 (65)  
   Median (range) 51 (18–68) 52 (19–70) 0.815a
  Older: ≥60 (−70) 65 (35) 71 (35)  
   Median (range) 68 (60–86) 68 (57–81) 0.101a
AML subtype, N (%)    0.091b
  de novo AML 143 (78) 154 (76)  
  AML secondary to MDS (s-AML) 22 (12) 37 (18)  
  AML therapy-related (t-AML) 19 (10) 12 (6)  
Blasts in bone marrow, %    0.551a
  Median 65 68  
  Range 10‒97 6‒100  
LDH, U/L    0.721a
 Median (range) 334 (107–4833) 356 (117–3431)  
ECOG, N (%)    0.631b
  0 65 (36) 62 (31)  
  1 94 (52) 107 (53)  
  2 17 (9) 23 (11)  
  3 5 (3) 7 (4)  
  4 0 2 (1)  
 Missing/unknown 3 2  
Karyotype, N (%)    0.006b
  Favorable 15 (9) 5 (3)  
  Intermediate 104 (65) 146 (78)  
  Unfavorable 41 (26) 37 (20)  
  Missing/unknown 24 15  
Molecular aberrations, N (%)    0.178b
 NPM1
   Pos. 53 (33) 74 (41)  
   Neg. 106 (67) 107 (59)  
   Missing/unknown 25 22  
 FLT3-ITD    0.895b
   Pos. 34 (21) 38 (21)  
   Neg. 125 (79) 146 (79)  
   Missing/unknown 25 19  
 FLT3-TKD    1.000b
   Pos. 11 (8) 10 (8)  
   Neg. 120 (92) 121 (92)  
  Unknown 53 72  
 MLL-PTD    0.554b
   Pos. 11 (7) 17 (9)  
   Neg. 143 (93) 164 (91)  
  Missing/unknown 30 22  
 CEBPA    0.676b
   Pos. 4 (11) 2 (6)  
   Neg. 32 (89) 30 (94)  
   Missing/unknown 148 171