Table 5.

Study drug–related adverse events in core (n = 17) and extension phase (n = 9)

 Core (n = 17) an (%)Extension (n = 9) bn (%)All patients (n = 17) n (%)
Preferred termAny gradeGrade 3Any gradeGrade 3Any gradeGrade 3
Any adverse event17 (100.0)4 (23.5)9 (100.0)2 (22.2)17 (100.0)5 (29.4)
Diarrhea12 (70.6)2 (11.8)3 (33.3)2 (22.2)13 (76.5)3 (17.6)
Asthenia/fatigue7 (41.2)03 (33.3)08 (47.1)0
Nausea6 (35.3)01 (11.1)07 (41.2)0
Peripheral neuropathy4 (23.4)03 (33.3)06 (35.3)0
Anorexia3 (17.6)02 (22.2)05 (29.4)0
Dehydration5 (29.4)1 (5.9)05 (29.4)1 (5.9)
Abdominal pain2 (11.8)01 (11.1)03 (17.6)0
Anemia1 (5.9)01 (11.1)02 (11.8)0
Dysgeusia1 (5.9)01 (11.1)02 (11.8)0
Increased INR/PT2 (11.8)2 (11.8)002 (11.8)2 (11.8)
Neutropenia1 (5.9)1 (5.9)001 (5.9)1 (5.9)
Vomiting2 (11.8)0002 (11.8)0
Arthralgia1 (5.9)0001 (5.9)0
Malaise1 (5.9)01 (5.9)0
Myalgia1 (5.9)0001 (5.9)0
Weight decrease1 (5.9)0001 (5.9)0

NOTE: Results are reported in number of patients; no patient developed drug-related grade 4 adverse event.

  • aCore study: Includes data from first 2 cycles with administration of warfarin (20 mg) on day 1, patupilone 10 mg/m2 on day 8, and concomitant administration of warfarin (20 mg) with patipulone (10 mg/m2) on day 29.

  • bExtension study, includes data from cycle 3 onward when patupilone was administered at 10 mg/m2 every 3 weeks.