Table 4.

Summary of treatment-related, nonhematologic adverse events and all-causality hematologic and chemistry abnormalities occurring with a frequency of ≥10% in either schedule (maximum grade, all cycles)

Adverse eventSchedule A (n = 13)Schedule B (n = 21)
Grade 1/2, n (%)Grade 3, n (%)Grade 4, n (%)Grade 1/2, n (%)Grade 3, n (%)Grade 4, n (%)
Nonhematologic, treatment related*
Diarrhea6 (46)1 (8)014 (67)1 (5)1 (5)
Fatigue4 (31)008 (38)2 (10)0
Rash5 (38)1 (8)07 (33)00
Vomiting5 (38)007 (33)00
Nausea5 (38)006 (29)00
Dermatitis acneiform1 (8)007 (33)00
Confusional state3 (23)1 (8)03 (14)1 (5)0
Vision blurred5 (38)001 (5)00
Peripheral edema2 (15)004 (19)00
Facial edema2 (15)004 (19)00
Visual disturbance4 (31)001 (5)00
Dry mouth2 (15)003 (14)00
Dyspnea2 (15)1 (8)01 (5)1 (5)0
Dizziness1 (8)003 (14)00
Dehydration00002 (10)1 (5)
Constipation0003 (14)00
Myalgia1 (8)002 (10)00
Asthenia1 (8)002 (10)00
Weight gain1 (8)002 (10)00
Headache1 (8)002 (10)00
Hallucination1 (8)1 (8)01 (5)00
Dyspepsia2 (15)001 (5)00
Diplopia0002 (10)00
Abdominal pain0002 (10)00
Upper abdominal pain0002 (10)00
Agitation0002 (10)00
Cough0002 (10)00
Dry skin0002 (10)00
Pruritus0002 (10)00
Erythematous rash0002 (10)00
Epistaxis2 (15)00000
Hematologic and chemistry abnormalities, all causality
Anemia6 (46)0010 (48)00
Lymphopenia3 (23)3 (23)1 (8)5 (24)3 (14)0
Hypoalbuminemia6 (46)009 (43)00
Hyperglycemia3 (23)009 (43)1 (5)0
Alkaline phosphatase3 (23)1 (8)06 (29)00
Hyponatremia2 (15)1 (8)05 (24)00
Hypocalcemia2 (15)01 (8)4 (19)00
Hypokalemia2 (15)003 (14)00
AST2 (15)001 (5)1 (5)0
ALT2 (15)001 (5)1 (5)0
Thrombocytopenia1 (8)002 (10)00
Hypophosphatemia0002 (10)00

Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase.

  • *Treatment related.

  • All causes; includes random glucose in some tests.