Table 3.

Treatment-emergent adverse events (TEAEs), regardless of causality (events occurring in ≥20% of patients)

Investigator assessed TEAEsa (N = 132)Grade 1 (%)Grade 2 (%)Grade 3 (%)Grade 4 (%)All grades (%)
Diarrhea41.728.819.7090.2
Fatigue21.231.112.9065.2
Nausea39.420.54.5064.4
Decreased appetite28.014.43.0045.5
Abdominal pain22.014.42.3038.6
Vomiting22.710.61.5034.8
Headache13.66.80020.5
Lab abnormalitiesb
 Creatinine increased46.950.80.8098.5
 White blood cell decreased18.544.627.7090.8
 Neutrophil count decreased17.743.122.34.687.7c
 Anemia30.038.50068.5
 Platelet count decreased28.910.22.3041.4
 Alanine aminotransferase increased24.61.53.8030.0
 Alkaline phosphatase increased16.97.71.5026.2
 Hypokalemia020.85.4026.2
 Hyponatremia17.703.1020.8
  • aCTCAE Version 4.0.

  • bN = 130 for laboratory abnormalities listed, except platelet count decreased (N = 128).

  • cOne patient who received cytotoxic chemotherapy within the 30-day follow-up window experienced febrile neutropenia.