Table 2:
Placebo plus axitinib | Dalantercept plus axitinib | p value | |
---|---|---|---|
n=61 | n=58 | ||
Complete response | 0 | 0 | |
95% CI | N/A | N/A | |
Partial response | 15 (24·6%) | 11 (19·0%) | |
95% CI | 14·5–37·3 | 9·9–31·4 | |
Stable disease | 35 (57·4%) | 37 (63·8%) | |
95% CI | 44·1–70·0 | 50·1–76·0 | |
Progressive disease | 10 (16·4%) | 10 (17·2%) | |
95% CI | 8·2–28·1 | 8·6–29·4 | |
Not evaluable | 1 (1·6%) | 0 | |
95% CI | 0·0–8·8 | N/A | |
Objective response rate | 15 (24·6%) | 11 (19·0%) | 0·432 |
95% CI | 14·5–37·3 | 9·9–31·4 | |
Disease control rate | 50 (82·0) | 48 (82·8) | 0·904 |
95% CI | 70·0–90·6 | 70·6–91·4 |
Data are from the all-treated set (all randomized patients who received study drug) and are n (%) unless otherwise noted. p value was calculated using Cochran-Mantel-Haenszel adjusted for randomization strata. Objective response rate was defined as the proportion of patients who achieved either CR or PR. Disease control rate was defined as the proportion of patients evaluable for response who met the criteria for CR, PR, or SD regardless of confirmation of complete response or partial response.
CI=confidence interval. CR=complete response N/A=not applicable. PR=partial response. SD=stable disease.