Table 4.

Most frequent toxicities stratified by grade and patient stratum

Stratum A* (15 patients, 44 cycles)
Stratum B (19 patients, 56 cycles)
Grade 1-2
Grade 3-4§
Grade 1-2
Grade 3-4§
ToxicityNo. events (%)ToxicityNo. events (%)ToxicityNo. events (%)ToxicityNo. events (%)
Hemoglobin9 (60)Mucositis5 (33)Rash14 (74)Diarrhea6 (32)
Rash9 (60)Diarrhea3 (20)Mucositis13 (68)AST/ALT2 (11)
Diarrhea6 (40)Seizures3 (20)Diarrhea8 (42)Hypertriglyceridemia2 (11)
Infection6 (40)Infection2 (13)Fatigue7 (37)Hypercholesterolemia1 (5)
Thrombocytopenia6 (40)Thrombocytopenia2 (13)Hemoglobin6 (32)Mucositis1 (5)
Hypertriglyceridemia5 (33)Thrombosis2 (13)Leukopenia6 (32)Seizures1 (5)
Fatigue4 (27)Hypercholesterolemia1 (4)Infection5 (26)Thrombosis1 (5)
Leukopenia4 (27)Dehydration1 (4)Hypercholesterolemia4 (21)
Hypercholesterolemia3 (20)Nausea/emesis1 (4)Hypertriglyceridemia4 (21)
Rash1 (4)Thrombocytopenia4 (21)
Weight loss1 (4)AST/ALT3 (16)
Nausea/emesis3 (16)
  • Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase.

  • * Stratum A: patients not on EIAEDs (phenytoin, carbamazepine, oxcarbazepine, phenobarbitol, and primidone).

  • Stratum B: patients on EIAEDs (phenytoin, carbamazepine, oxcarbazepine, phenobarbitol, and primidone).

  • Includes only grade 1 and 2 events that occurred at a minimum of three times.

  • § Includes all grade 3 and 4 events including those reported as DLT.

  • Cumulative number of events observed among all cycles of therapy.

  • Percentage of all patients in stratum.