Summary of overall survival in the overall study population and by disease extent and region
| . | Overall study population . | Japan . | North America . | European Union . | ||||
|---|---|---|---|---|---|---|---|---|
| Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | |
| Overall | ||||||||
| No. of patients | 314 | 316 | 58 | 56 | 77 | 81 | 132 | 132 |
| No. of events (%) | 118 (37.6) | 120 (38.0) | 15 (25.9) | 15 (26.8) | 45 (58.4) | 44 (54.3) | 41 (31.1) | 41 (31.1) |
| Follow-up period | ||||||||
| Median, months | 4.4 | 4.8 | 5.1 | 5.4 | 4.3 | 5.1 | 4.1 | 4.7 |
| (range) | (0.02–12.8) | (0.02–11.9) | (0.02–12.3) | (1.8–10.5) | (0.2–12.1) | (0.4–11.9) | (0.02–12.8) | (0.02–10.6) |
| Median OS, months | 8.5 | 8.3 | NE | 9.9 | 5.6 | 6.6 | 10.1 | 8.7 |
| (95% CI) | (6.9–9.5) | (6.9–10.3) | (7.4–NE) | (7.4–10.5) | (4.6–8.5) | (5.3–10.3) | (6.9–NE) | (7.1–NE) |
| Hazard ratioa,b (95% CI) | 1.014 (0.786–1.309) | 1.093 (0.525–2.274) | 1.288 (0.849–1.954) | 1.018 (0.659–1.571) | ||||
| P valuec | 0.5436 | 0.5937 | 0.8845 | 0.5309 | ||||
| Locally advanced disease | ||||||||
| No. of patients | 76 | 75 | 18 | 19 | 15 | 16 | 33 | 33 |
| No. of events (%) | 21 (27.6) | 13 (17.3) | 3 (16.7) | 3 (15.8) | 8 (53.3) | 5 (31.3) | 7 (21.2) | 4 (12.1) |
| Follow-up period | ||||||||
| Median, months | 5.1 | 6.0 | 6.0 | 6.8 | 3.0 | 5.5 | 4.2 | 6.0 |
| (range) | (0.02–10.6) | (0.4–11.9) | (0.02–10.3) | (2.9–10.5) | (1.3–10.0) | (1.4–11.9) | (0.02–10.6) | (0.4–10.6) |
| Median OS, months | 9.5 | 10.6 | NE | 9.9 | 6.3 | NE | 10.1 | 10.4 |
| (95% CI) | (7.4–NE) | (9.9–NE) | (8.0–NE) | (9.9–10.5) | (3.0–9.5) | (5.0–NE) | (7.3–NE) | (10.4–NE) |
| Hazard ratioa (95% CI) | 2.079 (1.031–4.189) | 1.939 (0.319–11.787) | 2.273 (0.741–6.974) | 2.351 (0.684–8.086) | ||||
| P valued | 0.9818 | 0.7678 | 0.9330 | 0.9187 | ||||
| Metastatic disease | ||||||||
| No. of patients | 238 | 241 | 40 | 37 | 62 | 65 | 99 | 99 |
| No. of events (%) | 97 (40.8) | 107 (44.4) | 12 (30.0) | 12 (32.4) | 37 (59.7) | 39 (60.0) | 34 (34.3) | 37 (37.4) |
| Follow-up period | ||||||||
| Median, months | 4.3 | 4.4 | 4.9 | 4.8 | 4.4 | 5.1 | 4.0 | 4.3 |
| (range) | (0.2–12.8) | (0.02–11.7) | (1.1–12.3) | (1.8–10.4) | (0.2–12.1) | (0.4–11.7) | (0.5–12.8) | (0.02–9.8) |
| Median OS, months | 7.0 | 6.9 | NE | NE | 5.5 | 6.2 | 7.5 | 8.2 |
| (95% CI) | (5.8–9.3) | (6.2–8.0) | (6.9–NE) | (6.4–NE) | (4.3–8.5) | (5.2–8.0) | (6.1–NE) | (6.4–NE) |
| Hazard ratioa (95% CI) | 0.904 (0.686–1.190) | 0.972 (0.435–2.170) | 1.170 (0.746–1.837) | 0.897 (0.563–1.430) | ||||
| P valued | 0.2345 | 0.4721 | 0.2456 | 0.3230 | ||||
| . | Overall study population . | Japan . | North America . | European Union . | ||||
|---|---|---|---|---|---|---|---|---|
| Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | |
| Overall | ||||||||
| No. of patients | 314 | 316 | 58 | 56 | 77 | 81 | 132 | 132 |
| No. of events (%) | 118 (37.6) | 120 (38.0) | 15 (25.9) | 15 (26.8) | 45 (58.4) | 44 (54.3) | 41 (31.1) | 41 (31.1) |
| Follow-up period | ||||||||
| Median, months | 4.4 | 4.8 | 5.1 | 5.4 | 4.3 | 5.1 | 4.1 | 4.7 |
| (range) | (0.02–12.8) | (0.02–11.9) | (0.02–12.3) | (1.8–10.5) | (0.2–12.1) | (0.4–11.9) | (0.02–12.8) | (0.02–10.6) |
| Median OS, months | 8.5 | 8.3 | NE | 9.9 | 5.6 | 6.6 | 10.1 | 8.7 |
| (95% CI) | (6.9–9.5) | (6.9–10.3) | (7.4–NE) | (7.4–10.5) | (4.6–8.5) | (5.3–10.3) | (6.9–NE) | (7.1–NE) |
| Hazard ratioa,b (95% CI) | 1.014 (0.786–1.309) | 1.093 (0.525–2.274) | 1.288 (0.849–1.954) | 1.018 (0.659–1.571) | ||||
| P valuec | 0.5436 | 0.5937 | 0.8845 | 0.5309 | ||||
| Locally advanced disease | ||||||||
| No. of patients | 76 | 75 | 18 | 19 | 15 | 16 | 33 | 33 |
| No. of events (%) | 21 (27.6) | 13 (17.3) | 3 (16.7) | 3 (15.8) | 8 (53.3) | 5 (31.3) | 7 (21.2) | 4 (12.1) |
| Follow-up period | ||||||||
| Median, months | 5.1 | 6.0 | 6.0 | 6.8 | 3.0 | 5.5 | 4.2 | 6.0 |
| (range) | (0.02–10.6) | (0.4–11.9) | (0.02–10.3) | (2.9–10.5) | (1.3–10.0) | (1.4–11.9) | (0.02–10.6) | (0.4–10.6) |
| Median OS, months | 9.5 | 10.6 | NE | 9.9 | 6.3 | NE | 10.1 | 10.4 |
| (95% CI) | (7.4–NE) | (9.9–NE) | (8.0–NE) | (9.9–10.5) | (3.0–9.5) | (5.0–NE) | (7.3–NE) | (10.4–NE) |
| Hazard ratioa (95% CI) | 2.079 (1.031–4.189) | 1.939 (0.319–11.787) | 2.273 (0.741–6.974) | 2.351 (0.684–8.086) | ||||
| P valued | 0.9818 | 0.7678 | 0.9330 | 0.9187 | ||||
| Metastatic disease | ||||||||
| No. of patients | 238 | 241 | 40 | 37 | 62 | 65 | 99 | 99 |
| No. of events (%) | 97 (40.8) | 107 (44.4) | 12 (30.0) | 12 (32.4) | 37 (59.7) | 39 (60.0) | 34 (34.3) | 37 (37.4) |
| Follow-up period | ||||||||
| Median, months | 4.3 | 4.4 | 4.9 | 4.8 | 4.4 | 5.1 | 4.0 | 4.3 |
| (range) | (0.2–12.8) | (0.02–11.7) | (1.1–12.3) | (1.8–10.4) | (0.2–12.1) | (0.4–11.7) | (0.5–12.8) | (0.02–9.8) |
| Median OS, months | 7.0 | 6.9 | NE | NE | 5.5 | 6.2 | 7.5 | 8.2 |
| (95% CI) | (5.8–9.3) | (6.2–8.0) | (6.9–NE) | (6.4–NE) | (4.3–8.5) | (5.2–8.0) | (6.1–NE) | (6.4–NE) |
| Hazard ratioa (95% CI) | 0.904 (0.686–1.190) | 0.972 (0.435–2.170) | 1.170 (0.746–1.837) | 0.897 (0.563–1.430) | ||||
| P valued | 0.2345 | 0.4721 | 0.2456 | 0.3230 | ||||
Gem, gemcitabine; OS, overall survival; CI, confidence interval; NE, not estimable.
aAxitinib/gemcitabine vs. placebo/gemcitabine; assuming proportional hazards model, a hazard ratio <1 indicates a reduction in hazard rate in favor of axitinib/gemcitabine and a hazard ratio >1 indicates a reduction in favor of placebo/gemcitabine.
bHazard ratio stratified by extent of the disease (locally advanced vs. metastatic pancreatic cancer).
cFrom a one-sided log-rank test of treatment stratified by extent of the disease (locally advanced vs. metastatic pancreatic cancer).
dFrom a one-sided, unstratified log-rank test.
Summary of overall survival in the overall study population and by disease extent and region
| . | Overall study population . | Japan . | North America . | European Union . | ||||
|---|---|---|---|---|---|---|---|---|
| Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | |
| Overall | ||||||||
| No. of patients | 314 | 316 | 58 | 56 | 77 | 81 | 132 | 132 |
| No. of events (%) | 118 (37.6) | 120 (38.0) | 15 (25.9) | 15 (26.8) | 45 (58.4) | 44 (54.3) | 41 (31.1) | 41 (31.1) |
| Follow-up period | ||||||||
| Median, months | 4.4 | 4.8 | 5.1 | 5.4 | 4.3 | 5.1 | 4.1 | 4.7 |
| (range) | (0.02–12.8) | (0.02–11.9) | (0.02–12.3) | (1.8–10.5) | (0.2–12.1) | (0.4–11.9) | (0.02–12.8) | (0.02–10.6) |
| Median OS, months | 8.5 | 8.3 | NE | 9.9 | 5.6 | 6.6 | 10.1 | 8.7 |
| (95% CI) | (6.9–9.5) | (6.9–10.3) | (7.4–NE) | (7.4–10.5) | (4.6–8.5) | (5.3–10.3) | (6.9–NE) | (7.1–NE) |
| Hazard ratioa,b (95% CI) | 1.014 (0.786–1.309) | 1.093 (0.525–2.274) | 1.288 (0.849–1.954) | 1.018 (0.659–1.571) | ||||
| P valuec | 0.5436 | 0.5937 | 0.8845 | 0.5309 | ||||
| Locally advanced disease | ||||||||
| No. of patients | 76 | 75 | 18 | 19 | 15 | 16 | 33 | 33 |
| No. of events (%) | 21 (27.6) | 13 (17.3) | 3 (16.7) | 3 (15.8) | 8 (53.3) | 5 (31.3) | 7 (21.2) | 4 (12.1) |
| Follow-up period | ||||||||
| Median, months | 5.1 | 6.0 | 6.0 | 6.8 | 3.0 | 5.5 | 4.2 | 6.0 |
| (range) | (0.02–10.6) | (0.4–11.9) | (0.02–10.3) | (2.9–10.5) | (1.3–10.0) | (1.4–11.9) | (0.02–10.6) | (0.4–10.6) |
| Median OS, months | 9.5 | 10.6 | NE | 9.9 | 6.3 | NE | 10.1 | 10.4 |
| (95% CI) | (7.4–NE) | (9.9–NE) | (8.0–NE) | (9.9–10.5) | (3.0–9.5) | (5.0–NE) | (7.3–NE) | (10.4–NE) |
| Hazard ratioa (95% CI) | 2.079 (1.031–4.189) | 1.939 (0.319–11.787) | 2.273 (0.741–6.974) | 2.351 (0.684–8.086) | ||||
| P valued | 0.9818 | 0.7678 | 0.9330 | 0.9187 | ||||
| Metastatic disease | ||||||||
| No. of patients | 238 | 241 | 40 | 37 | 62 | 65 | 99 | 99 |
| No. of events (%) | 97 (40.8) | 107 (44.4) | 12 (30.0) | 12 (32.4) | 37 (59.7) | 39 (60.0) | 34 (34.3) | 37 (37.4) |
| Follow-up period | ||||||||
| Median, months | 4.3 | 4.4 | 4.9 | 4.8 | 4.4 | 5.1 | 4.0 | 4.3 |
| (range) | (0.2–12.8) | (0.02–11.7) | (1.1–12.3) | (1.8–10.4) | (0.2–12.1) | (0.4–11.7) | (0.5–12.8) | (0.02–9.8) |
| Median OS, months | 7.0 | 6.9 | NE | NE | 5.5 | 6.2 | 7.5 | 8.2 |
| (95% CI) | (5.8–9.3) | (6.2–8.0) | (6.9–NE) | (6.4–NE) | (4.3–8.5) | (5.2–8.0) | (6.1–NE) | (6.4–NE) |
| Hazard ratioa (95% CI) | 0.904 (0.686–1.190) | 0.972 (0.435–2.170) | 1.170 (0.746–1.837) | 0.897 (0.563–1.430) | ||||
| P valued | 0.2345 | 0.4721 | 0.2456 | 0.3230 | ||||
| . | Overall study population . | Japan . | North America . | European Union . | ||||
|---|---|---|---|---|---|---|---|---|
| Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | Axitinib/Gem . | Placebo/Gem . | |
| Overall | ||||||||
| No. of patients | 314 | 316 | 58 | 56 | 77 | 81 | 132 | 132 |
| No. of events (%) | 118 (37.6) | 120 (38.0) | 15 (25.9) | 15 (26.8) | 45 (58.4) | 44 (54.3) | 41 (31.1) | 41 (31.1) |
| Follow-up period | ||||||||
| Median, months | 4.4 | 4.8 | 5.1 | 5.4 | 4.3 | 5.1 | 4.1 | 4.7 |
| (range) | (0.02–12.8) | (0.02–11.9) | (0.02–12.3) | (1.8–10.5) | (0.2–12.1) | (0.4–11.9) | (0.02–12.8) | (0.02–10.6) |
| Median OS, months | 8.5 | 8.3 | NE | 9.9 | 5.6 | 6.6 | 10.1 | 8.7 |
| (95% CI) | (6.9–9.5) | (6.9–10.3) | (7.4–NE) | (7.4–10.5) | (4.6–8.5) | (5.3–10.3) | (6.9–NE) | (7.1–NE) |
| Hazard ratioa,b (95% CI) | 1.014 (0.786–1.309) | 1.093 (0.525–2.274) | 1.288 (0.849–1.954) | 1.018 (0.659–1.571) | ||||
| P valuec | 0.5436 | 0.5937 | 0.8845 | 0.5309 | ||||
| Locally advanced disease | ||||||||
| No. of patients | 76 | 75 | 18 | 19 | 15 | 16 | 33 | 33 |
| No. of events (%) | 21 (27.6) | 13 (17.3) | 3 (16.7) | 3 (15.8) | 8 (53.3) | 5 (31.3) | 7 (21.2) | 4 (12.1) |
| Follow-up period | ||||||||
| Median, months | 5.1 | 6.0 | 6.0 | 6.8 | 3.0 | 5.5 | 4.2 | 6.0 |
| (range) | (0.02–10.6) | (0.4–11.9) | (0.02–10.3) | (2.9–10.5) | (1.3–10.0) | (1.4–11.9) | (0.02–10.6) | (0.4–10.6) |
| Median OS, months | 9.5 | 10.6 | NE | 9.9 | 6.3 | NE | 10.1 | 10.4 |
| (95% CI) | (7.4–NE) | (9.9–NE) | (8.0–NE) | (9.9–10.5) | (3.0–9.5) | (5.0–NE) | (7.3–NE) | (10.4–NE) |
| Hazard ratioa (95% CI) | 2.079 (1.031–4.189) | 1.939 (0.319–11.787) | 2.273 (0.741–6.974) | 2.351 (0.684–8.086) | ||||
| P valued | 0.9818 | 0.7678 | 0.9330 | 0.9187 | ||||
| Metastatic disease | ||||||||
| No. of patients | 238 | 241 | 40 | 37 | 62 | 65 | 99 | 99 |
| No. of events (%) | 97 (40.8) | 107 (44.4) | 12 (30.0) | 12 (32.4) | 37 (59.7) | 39 (60.0) | 34 (34.3) | 37 (37.4) |
| Follow-up period | ||||||||
| Median, months | 4.3 | 4.4 | 4.9 | 4.8 | 4.4 | 5.1 | 4.0 | 4.3 |
| (range) | (0.2–12.8) | (0.02–11.7) | (1.1–12.3) | (1.8–10.4) | (0.2–12.1) | (0.4–11.7) | (0.5–12.8) | (0.02–9.8) |
| Median OS, months | 7.0 | 6.9 | NE | NE | 5.5 | 6.2 | 7.5 | 8.2 |
| (95% CI) | (5.8–9.3) | (6.2–8.0) | (6.9–NE) | (6.4–NE) | (4.3–8.5) | (5.2–8.0) | (6.1–NE) | (6.4–NE) |
| Hazard ratioa (95% CI) | 0.904 (0.686–1.190) | 0.972 (0.435–2.170) | 1.170 (0.746–1.837) | 0.897 (0.563–1.430) | ||||
| P valued | 0.2345 | 0.4721 | 0.2456 | 0.3230 | ||||
Gem, gemcitabine; OS, overall survival; CI, confidence interval; NE, not estimable.
aAxitinib/gemcitabine vs. placebo/gemcitabine; assuming proportional hazards model, a hazard ratio <1 indicates a reduction in hazard rate in favor of axitinib/gemcitabine and a hazard ratio >1 indicates a reduction in favor of placebo/gemcitabine.
bHazard ratio stratified by extent of the disease (locally advanced vs. metastatic pancreatic cancer).
cFrom a one-sided log-rank test of treatment stratified by extent of the disease (locally advanced vs. metastatic pancreatic cancer).
dFrom a one-sided, unstratified log-rank test.
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