Table 2.

Adverse events (≥15% incidence overall) related to YM155

Adverse event/YM155 dose (mg/m2/d)No. of patients experiencing toxicity during first course (all courses)
1.8 (n = 3)
3.6 (n = 6)
4.8 (n = 6)
6.0 (n = 7)
8.0 (n = 6)
10.6 (n = 5)
All (n = 33)
Grade of adverse eventG1/2G3G1/2G3G1/2G3G1/2G3G1/2G3G1/2G3/4G1/2G3/4
Urine microalbumin present000(1)01(1)01(1)04(4)05(5)011 (12)0
Fever001(2)0002(3)02(2)04(4)09 (11)0
Decreased hemoglobin/anemia000(1)01(1)01(2)01(1)03(3)1(1)*6 (8)1 (1)
Injection site phlebitis2(3)02(4)02(2)02(2)0000(1)08 (12)
Fatigue1(1)00(1)00(1)01(1)01(1)02(2)05 (7)
Decreased blood albumin00001(1)01(1)02(2)04(4)08 (8)
Decreased lymphocyte count0001(1)01(1)1(1)001(1)04(4)1 (1)7 (7)
Abnormal liver function test§0(1)00(1)0002(2)1(1)001(1)03 (5)1 (1)
Increased C-reactive protein00000010202(3)05 (6)
Urine protein present0000000010405 (5)
  • NOTE: * and are the same patient.

  • * Grade 4.

  • An event after dose reduction to 8.0 mg/m2/d in one patient.

  • Grade 4 in one patient.

  • § Abnormal liver function test includes increased aspartate, increased alanine serum transaminase, and increased γ-glutamyl transpeptidase.