Table 2. The best overall response (rederived and by investigator assessment) as per RECIST at week 12 on study and at the end of treatment.
| Time-point variable | N=38 n (%) | 90% confidence intervala |
|---|---|---|
|
Week 12 (rederived) | ||
| CR | 0 | |
| PR | 1 (2.6) | |
| SD | 19 (50.0) | |
| PD | 5 (13.2) | |
| Unknown | 13 (34.2) | |
| ORR (CR or PR) | 1 (2.6) | (0.1–11.9) |
| DCR (CR or PR or SD) | 20 (52.6) | (38.2–66.7) |
|
Week 12 (by investigator assessment) | ||
| CR | 0 | |
| PR | 1 (2.6) | |
| SD | 20 (52.6) | |
| PD | 5 (13.2) | |
| Unknown | 12 (31.6) | |
| ORR (CR or PR) | 1 (2.6) | (0.1–11.9) |
| DCR (CR or PR or SD) | 21 (55.3) | (40.7–69.1) |
|
End of treatment (rederived) | ||
| CR | 0 | |
| PR | 2 (5.3) | |
| SD | 18 (47.4) | |
| PD | 5 (13.2) | |
| Unknown | 13 (34.2) | |
| ORR (CR or PR) | 2 (5.3) | (0.9–15.7) |
| DCR (CR or PR or SD) | 20 (52.6) | (38.2–66.7) |
|
End of treatment (by investigator assessment) | ||
| CR | 0 | |
| PR | 2 (5.3) | |
| SD | 21 (55.3) | |
| PD | 5 (13.2) | |
| Unknown | 10 (26.3) | |
| ORR (CR or PR) | 2 (5.3) | (0.9–15.7) |
| DCR (CR or PR or SD) | 23 (60.5) | (45.9–73.9) |
Abbreviations: CR=complete response; DCR=disease control rate; ORR=overall response rate; PD=progressive disease; PR=partial response; SD=stable disease.
The recalculated best overall response is presented together with the investigator assessment. Assessments taken more than 28 days after last dose of study treatment are excluded from derivation of best overall response.
a
Exact binomial confidence interval.