Table 2.

Confirmed best overall response

	Confirmed best overall response* (n=88)
Complete response	8 (9%)
Partial response	20 (23%)
Stable disease	9 (10%)
Progressive disease	32 (36%)
Non-complete response/non-progressive disease†	1 (1%)
Non-assessable‡	18 (20%)
Objective response§	31·8%(21·9–43·1)

Data are n (%) or % (95·9% CI).

^*Confirmed best overall response was according to independent review committee assessment and Response Evaluation Criteria in Solid Tumors version 1.1.

^†One patient did not have measurable disease at baseline and thus a best overall response of partial response or stable disease could not be distinguished.

^‡Patients not assessable for a confirmed best overall response had no baseline lesions identified by the independent review committee (n=4), baseline but no post-baseline assessments (n=10; four patients died within 6 weeks after the start of treatment and six additional patients discontinued study treatment in the first 6 weeks), all non-assessable post-baseline assessments (n=2), no post-baseline tumour assessment before the start of new anticancer therapy (n=1), or stable disease of insufficient duration (<6 weeks after start date without further tumour assessment; n=1).

^§A repeated CI for the objective response in the modified intention-to-treat analysis set (95·9% CI for the primary analysis) was calculated to account for the group sequential testing approach.⁴⁰