Table 4.

Summary of all drug-related Common Toxicity Criteria grade 3 and 4 toxicities

ToxicityP600 arm (n = 47), n (%)P900 arm (n = 45), n (%)
Grade 3Grade 4Grade 3Grade 4
Hematologic
    Neutropenia7 (14.9)2 (4.3)4 (8.9)2 (4.4)
    Leukopenia3 (6.4)02 (4.4)2 (4.4)
    Anemia2 (4.3)01 (2.2)1 (2.2)
    Thrombocytopenia002 (4.4)0
Nonhematologic
    Alanine aminotransferase1 (2.1)02 (4.4)0
    Aspartate aminotransferase1 (2.1)000
    Alkaline phosphatase1 (2.1)000
    Hypocalcemia1 (2.1)01 (2.2)0
    Bilirubin1 (2.1)000
    Fatigue1 (2.1)01 (2.2)1 (2.2)
    Diarrhea2 (4.3)000
    Anorexia1 (2.1)000
    Nausea001 (2.2)0
    Febrile neutropenia001 (2.2)0
    Infection without neutropenia001 (2.2)0
    Renal failure001 (2.2)*0
    Other neurology001 (2.2)0
  • * This patient discontinued from the study due to renal failure. Another patient also discontinued from the study due to renal function–associated reasons, which was a grade 1 creatinine increase that persisted ≥9 d.