Table 4.

Summary of treatment-related, treatment-emergent adverse events during the treatment period

(A) Hematologic laboratory parameters that changed from grade 0-2 to grade 3 or 4 abnormalities by dose
Total
Lonafarnib dose (mg/twice daily)100100125150
Paclitaxel dose (mg/m2/wk)60808080
No. patients (n)777326
Hemoglobin1 (14.3)1 (14.3)2 (22.2)04 (15.4)
WBC1 (14.3)2 (28.6)3 (33.3)1 (33.3)7 (26.9)
Neutrophils01 (14.3)4 (44.4)1 (33.3)6 (23.1)
Platelets1 (14.3)01 (11.1)02 (7.7)
(B) Treatment-related, treatment-emergent, adverse events by descending frequency
Total
Lonafarnib dose (mg/twice daily)100100125150
Paclitaxel dose (mg/m2/wk)60808080
No. patients (n)7710327
Adverse event rate*
Any severity
Grade 3/4
Any severity
Grade 3/4
Any severity
Grade 3/4
Any severity
Grade 3/4
Any severity
Grade 3/4
Hematologic
    Neutropenia0000002 (67)2 (67)2 (7)2 (7)
    Anemia001 (14)1 (14)1 (10)1 (10)002 (7)2 (7)
Nonhematologic
    Diarrhea7 (100)2 (29)6 (86)07 (70)02 (67)022 (81)2 (7)
    Vomiting5 (71)2 (29)2 (29)1 (14)8 (80)01 (33)016 (59)3 (11)
    Dehydration3 (43)1 (14)1 (14)0001 (33)1 (33)5 (19)2 (7)
    Heart block1 (14)1 (14)0000001 (4)1 (4)
    Nausea5 (71)1 (14)4 (57)07 (70)1 (10)2 (67)018 (67)2 (7)
    Anorexia4 (47)02 (29)05 (50)1 (10)2 (67)1 (33)13 (48)2 (7)
    Cellulitis0000001 (33)1 (33)1 (4)1 (4)
    Edema (legs)1 (14)02 (29)0002 (67)1 (33)5 (19)1 (4)
    Fatigue5 (71)04 (57)08 (80)2 (20)2 (67)1 (33)19 (70)3 (11)
    Herpes zoster00001 (10)1 (10)001 (4)1 (4)
    Neuropathy2 (29)02 (29)1 (14)4 (40)0008 (30)1 (4)
    Rash002 (29)1 (14)002 (67)04 (15)1 (4)
  • * Values expressed as n (%).