Table 6 Adverse events occurring in greater than or equal to 5 % of patients in any group by preferred term in decreasing frequency (safety population)

933 (76.7)

471 (74.5)

362 (72.4)

161 (66.5)

47 (54.0)

32 (65.3)

54 (71.1)

30 (66.7)

351 (28.8)

198 (31.3)

40 (8.0)

23 (9.5)

4 (4.6)

6 (12.2)

7 (9.2)

5 (11.1)

287 (23.6)

130 (20.6)

28 (5.6)

18 (7.4)

5 (5.7)

7 (14.3)

1 (1.3)

6 (13.3)

216 (17.7)

128 (20.3)

32 (6.4)

14 (5.8)

1 (1.1)

0 (0.0)

6 (7.9)

4 (8.9)

163 (13.4)

94 (14.9)

39 (7.8)

14 (5.8)

4 (4.6)

2 (4.1)

6 (7.9)

2 (4.4)

107 (8.8)

65 (10.3)

69 (13.8)

43 (17.8)

8 (9.2)

5 (10.2)

12 (15.8)

7 (15.6)

103 (8.5)

49 (7.8)

16 (3.2)

11 (4.5)

2 (2.3)

2 (4.1)

6 (7.9)

0 (0.0)

85 (7.0)

47 (7.4)

50 (10.0)

22 (9.1)

10 (11.5)

13 (26.5)

7 (9.2)

8 (17.8)

75 (6.2)

58 (9.2)

22 (4.4)

14 (5.8)

1 (1.1)

1 (2.0)

1 (1.3)

3 (6.7)

51 (4.2)

33 (5.2)

14 (2.8)

6 (2.5)

3 (3.4)

1 (2.0)

2 (2.6)

0 (0.0)

41 (3.4)

15 (2.4)

29 (5.8)

12 (5.0)

2 (2.3)

0 (0.0)

2 (2.6)

0 (0.0)

39 (3.2)

21 (3.3)

24 (4.8)

19 (7.9)

2 (2.3)

7 (14.3)

6 (7.9)

2 (4.4)

34 (2.8)

10 (1.6)

33 (6.6)

15 (6.2)

8 (9.2)

4 (8.2)

8 (10.5)

8 (17.8)

26 (2.1)

16 (2.5)

4 (0.8)

2 (0.8)

3 (3.4)

5 (10.2)

2 (2.6)

1 (2.2)

16 (1.3)

3 (0.5)

9 (1.8)

2 (0.8)

2 (2.3)

4 (8.2)

0 (0.0)

1 (2.2)

14 (1.2)

13 (2.1)

1 (0.2)

4 (1.7)

0 (0.0)

5 (10.2)

2 (2.6)

0 (0.0)

15 (1.2)

6 (0.9)

3 (0.6)

5 (2.1)

0 (0.0)

0 (0.0)

4 (5.3)

2 (4.4)

15 (1.2)

17 (2.7)

9 (1.8)

6 (2.5)

2 (2.3)

1 (2.0)

0 (0.0)

3 (6.7)

13 (1.1)

17 (2.7)

13 (2.6)

10 (4.1)

4 (4.6)

1 (2.0)

3 (3.9)

3 (6.7)