|
Grade 3–4 AEs
|
18 (6)
|
24 (8)
|
21 (7)
|
|
Any AE
|
275 (88)
|
286 (91)
|
270 (92)
|
|
Any drug-related AE
|
123 (39)
|
128 (41)
|
122 (41)
|
|
Serious AEs
|
15 (5)
|
26 (8)
|
21 (7)
|
|
Deaths
|
0
|
0
|
0
|
|
AEs any grade, regardless of relationship to study treatment and occurring in ≥10% of patients
|
|
Diarrhea
|
78 (25)
|
86 (27)
|
80 (27)
|
|
Nausea
|
67 (21)
|
72 (23)
|
69 (23)
|
|
Upper respiratory tract infection
|
31 (10)
|
44 (14)
|
43 (15)
|
|
Headache
|
29 (9)
|
38 (12)
|
35 (12)
|
|
AEs leading to discontinuation*
|
|
Any, n
|
15 (5)
|
16 (5)
|
16 (5)
|
|
Maculo-papular rash
|
3 (1)
|
3 (1)
|
3 (1)
|
|
Rash
|
3 (1)
|
3 (1)
|
3 (1)
|
|
Nausea
|
2 (0.6)
|
2 (0.6)
|
2 (0.7)
|
|
Hypersensitivity
|
2 (0.6)
|
2 (0.6)
|
2 (0.7)
|
|
Idiopathic thrombocytopenic purpura
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Dyspepsia
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Vomiting
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Mycobacterium avium complex infection
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Headache
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Dysgeusia
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Renal tubular disorder
|
–
|
1 (0.3)
|
1 (0.3)
|
|
Allergic dermatitis
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Macular rash
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Vesicular rash
|
1 (0.3)
|
1 (0.3)
|
1 (0.3)
|
|
Treatment-emergent grade 3–4 laboratory abnormalities occurring in ≥2% patients
|
| |
n = 310
|
n = 310
|
n = 292
|
|
Increased creatine kinase
|
18 (6)
|
22 (7)
|
22 (8)
|
|
Increased alanine amino transferase
|
7 (2)
|
9 (3)
|
9 (3)
|
|
Increased aspartate amino transferase
|
6 (2)
|
8 (3)
|
7 (2)
|
|
Increased amylase
|
6 (2)
|
8 (3)
|
7 (2)
|
|
Increased lipase
|
5 (2)
|
7 (2)
|
7 (2)
|
