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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