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Table 2 Median relative dose intensities and duration of exposure in the Asian and non-Asian subsets (safety set)

From: Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1

 

Overall population

HR– subpopulation

Asian

Non-Asian

Asian

Non-Asian

EVE + TRAS + PAC

PBO + TRAS + PAC

EVE + TRAS + PAC

PBO + TRAS + PAC

EVE + TRAS + PAC

PBO + TRAS + PAC

EVE + TRAS + PAC

PBO + TRAS + PAC

n = 196

n = 104

n = 276

n = 134

n = 85

n = 47

n = 121

n = 56

Relative dose intensity, median (range)

 EVE

0.51 (0.03–1.00)

0.95 (0.01–1.00) (PBO)

0.57 (0.05–1.00)

0.97 (0.12–1.00) (PBO)

0.50 (0.03–1.00)

0.95 (0.13–1.00) (PBO)

0.61 (0.05–1.00)

0.96 (0.29–1.00) (PBO)

 TRAS

0.96 (0.28–1.08)

0.97 (0.75–1.03)

0.96 (0.08–1.16)

0.96 (0.41–1.06)

0.98 (0.49–1.08)

0.97 (0.78–1.02)

0.97 (0.37–1.12)

0.96 (0.61–1.03)

 PAC

0.65 (0.01–1.09)

0.72 (0.08–1.22)

0.72 (0.04–1.40)

0.84 (0.11–1.25)

0.65 (0.01–1.08)

0.82 (0.08–1.22)

0.73 (0.11–1.40)

0.79 (0.13–1.00)

Duration of exposure, median (range), weeks

 EVE

42.14 (0.6–241.7)

59.93 (2.0–240.7)

40.00 (1.1–233.1)

40.71 (1.1–207.4)

45.86 (0.6–210.4)

41.29 (2.1–221.1)

44.71 (1.4–233.1)

38.50 (1.1–207.4)

 TRAS

58.07 (3.0–242.3)

64.07 (3.0–241.0)

45.00 (1.0–233.7)

40.43 (1.0–208.0)

58.29 (3.0–211.0)

41.00 (3.0–221.9)

49.86 (2.0–233.7)

38.50 (4.0–208.0)

 PAC

36.50 (1.0–201.0)

37.14 (1.0–230.0)

27.07 (1.0–155.1)

30.00 (1.0–174.0)

35.00 (1.0–201.0)

35.00 (1.0–190.0)

28.86 (2.0–141.7)

27.00 (1.0–167.9)

  1. EVE everolimus, HR– hormone receptor-negative, PAC paclitaxel, PBO placebo, TRAS trastuzumab