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Table 2 Extent of Exposure: Number of cycles, treatment duration and total dose of BIBW 2992 (Safety Population)

From: Safety and efficacy of afatinib as add-on to standard therapy of gemcitabine/cisplatin in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, phase I trial with an extensive biomarker program

  Dose level 1 Dose level − 1 Total
Variable (N = 3) (N = 6) (N = 9)
Number of cycles of chemotherapy
 N 3 6 9
 Mean (SD) 5.33 (2.89) 4.50 (2.81) 4.78 (2.68)
 Min 2.0 2.0 2.0
 Median 7.00 3.50 4.00
 Max 7.0 8.0 8.0
 Missing 0 0 0
Duration of BIBW Treatment [months]
 N 3 6 9
 Mean (SD) 4.0 (2.5) 3.3 (2.3) 3.6 (2.2)
 Min 1.3 0.8 0.8
 Median 4.4 2.7 3.3
 Max 6.3 6.1 6.3
 Missing 0 0 0
Total number of BIBW 2992 doses
 N 3 6 9
 Mean (SD) 114.33 (53.50) 94.17 (67.54) 100.89 (60.57)
 Min 54.0 9.0 9.0
 Median 133.00 75.00 79.00
 Max 156.0 179.0 179.0
 Missing 0 0 0