Table 2 Treatment-emergent AEs and grade 3–4 laboratory abnormalities
|  | All patients | Treatment-naïve patients | |
|---|---|---|---|
Incidence, [n (%)] | Week 24 analysis | Week 48 analysis | Week 48 analysis |
N = 313 | N = 313 | N = 295 | |
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 | |||
| Â | 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) |