Table 2.

Efficacy analysis on the basis of local and central assessment

	ITT [n = 27]	Per protocol [n = 23]
Local assessment
Clinical benefit rate	18.5% (6.3–38.1%)	21.7% (7.4–43.7%)
Response at 6 month scan
Complete response	0	0
Partial response	0	0
Stable disease	5	5
Progressive disease	16	16
Dead	1	1
Withdrawal	5	1
Central assessment
Clinical benefit rate	14.8% (4.2–33.7%)	17.4% (5.0–38.8%)
Response at 6 month scan
Complete response	0	0
Partial response	0	0
Stable disease	4	4
Progressive disease	15	15
Dead	1	1
Withdrawala	7	3

ITT intent to treat; Prior to 3 month scan: three patients decided to withdraw; one patient withdrawn by local investigator. These four patients had no scan and were excluded in the per-protocol analysis; Between 3 and 6 month scan: one patient withdrawn

^aAt month 3: two patients PD reclassified as SD by central review and thus treated as withdrawals