Table 4.

Nonhematologic AEs and hematologic laboratory abnormalities

n (%)
Double-blind phaseOpen-label phaseDouble-blind and open-label phases
Sunitiniba (n = 228)Placeboa (n = 114)All patientsb(n = 255)Sunitinib (n = 241)
GradescGradescGradescGradesc
AE or laboratory abnormality1/23/41/23/41/23/41/23/4
Treatment-related nonhematologic AEsd
 Fatigue67 (29)18 (8)23 (20)2 (2)102 (40)26 (10)88 (37)25 (10)
 Diarrhea69 (30)8 (4)8 (7)0 (0)81(32)12 (5)91 (38)13 (5)
 Nausea60 (26)3 (1)14 (12)2 (2)74 (29)9 (4)82 (34)6 (3)
 Skin discoloration62 (27)0 (0)5 (4)0 (0)77 (30)0 (0)72 (30)0 (0)
 Anorexia46 (20)0 (0)5 (4)1 (1)58 (23)6 (2)66 (27)2 (1)
 Dysgeusia50 (22)0 (0)3 (3)0 (0)54 (21)1 (0.4)60 (25)1 (0.4)
 Vomiting38 (17)1 (0.4)7 (6)1 (1)44 (17)5 (2)51 (21)3 (1)
 Mucosal inflammation32 (14)1 (0.4)0 (0)0 (0)42 (17)6 (2)44 (18)4 (2)
 Hypertension18 (8)9 (4)4 (4)1 (1)39 (15)21 (8)29 (12)18 (8)
 Rash34 (15)2 (1)6 (5)0 (0)37 (15)1 (0.4)43 (18)3 (1)
 Stomatitis35 (15)1 (0.4)1 (1)0 (0)36 (14)4 (2)42 (17)3 (1)
 Dyspepsia33 (14)1 (0.4)1 (1)0 (0)45 (18)2 (1)44 (18)1 (0.4)
 Headache24 (11)1 (0.4)7 (6)0 (0)43 (17)3 (1)41 (17)3 (1)
 Asthenia25 (11)6 (3)2 (2)2 (2)31 (12)12 (5)30 (13)13 (5)
 Hand–foot syndrome16 (7)8 (4)1 (1)0 (0)44 (17)12 (5)29 (12)13 (5)
 Hair color changes19 (8)0 (0)2 (2)0 (0)50 (20)0 (0)37 (15)0 (0)
 Hypothyroidism6 (3)1 (0.4)1 (1)0 (0)35 (14)5 (2)26 (11)6 (2)
 Cardiac disorders22 (10)2 (1)2 (2)0 (0)14 (5)3 (1)25 (10)3 (1)
  Decreased EF15 (7)2 (1)2 (2)0 (0)3 (1)0 (0)16 (7)2 (1)
  LV dysfunction3 (1)0 (0)0 (0)0 (0)4 (2)1 (0.4)5 (2)0 (0)
Hematologic laboratory abnormalities
 Hemoglobin124 (54)9 (4)60 (53)2 (2)NDND132 (55)11 (5)
 Leukocytes126 (55)8 (4)7 (6)0 (0)NDND136 (56)8 (3)
 Neutrophils105 (46)23 (10)4 (4)0 (0)NDND113 (47)28 (12)
 Lymphocytes85 (37)26 (11)34 (30)2 (2)NDND58 (38)28 (12)
 Platelets87 (38)10 (4)3 (3)0 (0)NDND90 (37)10 (4)

Abbreviations: EF, ejection fraction; LV, left ventricular; ND, not determined.

  • aPer-protocol population.

  • bTreatment = sunitinib.

  • cGrade 5 events are described in the text.

  • dReported in 15% or more of patients based on the sunitinib arm over the entire study or of particular clinical interest.