Table 2.
Exposure to study drugsa
| Overall study population |
Japan |
North America |
European Union |
|||||
|---|---|---|---|---|---|---|---|---|
| Axitinib/Gem | Placebo/Gem | Axitinib/Gem | Placebo/Gem | Axitinib/Gem | Placebo/Gem | Axitinib/Gem | Placebo/Gem | |
| Gemcitabine | n = 305 | n = 308 | n = 57 | n = 56 | n = 75 | n = 81 | n = 127 | n = 126 |
| No. cycles startedb,c | ||||||||
| Median | 3 | 3 | 5 | 4 | 2 | 3 | 3 | 4 |
| Range | 1–13 | 1–12 | 1–10 | 1–10 | 1–9 | 1–12 | 1–13 | 1–10 |
| Days on treatmentc,d | ||||||||
| Median | 71 | 73 | 119 | 99 | 43 | 71 | 71 | 85 |
| Range | 1–336 | 1–358 | 1–267 | 1–267 | 1–232 | 1–334 | 1–336 | 1–358 |
| Dose interruption, n (%) | 194 (63.6) | 165 (53.6) | 33 (57.9) | 29 (51.8) | 54 (72.0) | 44 (54.3) | 73 (57.5) | 62 (49.2) |
| Dose reduction, n (%) | 125 (41.0) | 100 (32.5) | 37 (64.9) | 27 (48.2) | 23 (30.7) | 26 (32.1) | 42 (33.1) | 34 (27.0) |
| Relative dose intensityc,e, % | ||||||||
| Median | 77.4 | 79.4 | 70.1 | 72.8 | 70.8 | 78.8 | 81.7 | 83.0 |
| Range | 27.7–106.4 | 19.6–106.3 | 32.1–104.5 | 33.3–101.3 | 27.7–101.4 | 19.6–104.5 | 32.5–106.4 | 32.7–106.3 |
| Axitinib or placebo | n = 298 | n = 301 | n = 57 | n = 56 | n = 75 | n = 81 | n = 127 | n = 126 |
| Days on treatmentd,f | ||||||||
| Median | 84 | 85 | 95 | 88 | 63 | 84 | 84 | 111 |
| Range | 1–335 | 2–361 | 24–280 | 5–280 | 2–251 | 2–361 | 1–335 | 4–281 |
| Days on drugf,g | ||||||||
| Median | 84 | 84 | 91 | 88 | 59.5 | 84 | 84 | 91 |
| Range | 1–336 | 2–334 | 24–280 | 5–280 | 2–251 | 2–334 | 1–336 | 4–288 |
| Dose interruption, n (%) | 223 (74.8) | 183 (60.8) | 50 (87.7) | 36 (64.3) | 59 (78.7) | 60 (74.1) | 82 (64.6) | 61 (48.4) |
| Dose reduction, n (%) | 74 (24.8) | 30 (10.0) | 18 (31.6) | 4 (7.1) | 12 (16.0) | 8 (9.9) | 33 (26.0) | 12 (9.5) |
| Dose increase, n (%) | 95 (31.9) | 131 (43.5) | 7 (12.3) | 32 (57.1) | 16 (21.3) | 29 (35.8) | 51 (40.2) | 57 (45.2) |
| Relative dose intensitye,f, % | ||||||||
| Median | 100.0 | 100.0 | 100.0 | 117.1 | 100.0 | 100.0 | 100.0 | 100.0 |
| Range | 36.3–186.7 | 50.0–190.2 | 40.0–184.4 | 55.6–190.2 | 48.2–179.6 | 54.4–168.0 | 38.4–186.7 | 62.6–188.1 |
Gem, gemcitabine
aBased on patients who received study treatment.
bIf patients took at least some gemcitabine, they were considered to have started a cycle.
cn = 304 and 302 for Axitinib/Gem and Placebo/Gem, respectively, in the overall study population; n = 74 and 79 for Axitinib/Gem and Placebo/Gem, respectively, in North America; and n = 123 for Placebo/Gem in the European Union.
dTime period starting from date of the first dose to date of the last dose or data cutoff.
e(Actual total dose/intended total dose) × 100.
fn = 55 and 53 for Axitinib/Gem and Placebo/Gem, respectively, in Japan; n = 72 and 79 for Axitinib/Gem and Placebo/Gem, respectively, in North America; and n = 125 and 124 for Axitinib/Gem and Placebo/Gem, respectively, in the European Union.
gTotal number of days on which axitinib or placebo was actually administered.