Category | Concrete forms | Events/total (incidence rate, %) | RR (95 % CI) | p values | |
---|---|---|---|---|---|
DCV + P/R | PBO + P/R | ||||
Nonspecific AEs | Fatigue | 211 (49.76) | 62 (58.49) | 0.86 (0.72–1.03) | 0.11 |
Headache | 184 (43.40) | 48 (45.28) | 0.96 (0.76–1.21) | 0.73 | |
Insomnia | 132 (31.13) | 36 (33.96) | 0.86 (0.64–1.14) | 0.29 | |
Nausea | 126 (32.31) | 29 (29.59) | 0.79 (0.37–1.68) | 0.53 | |
Diarrhea | 90 (23.20) | 54 (57.45) | 0.52 (0.20–1.36) | 0.18 | |
Decreased appetite | 104 (24.53) | 26 (24.53) | 0.99 (0.69–1.44) | 0.98 | |
Cough | 72 (18.60) | 53 (54.08) | 0.66 (0.18–2.37) | 0.52 | |
Arthralgia | 66 (17.01) | 24 (25.53) | 0.67 (0.44–1.01) | 0.06 | |
Liver dysfunction | Elevated ALT | 9 (1.84) | 1 (0.69) | 1.51 (0.34–6.68) | 0.59 |
Elevated bilirubin | 4 (0.82) | 1 (0.69) | 0.87 (0.19–4.07) | 0.86 | |
Hematologic abnormalities | Anemia | 45 (8.59) | 14 (8.92) | 0.92 (0.53–1.59) | 0.77 |
Thrombocytopenia | 12 (2.46) | 6 (4.14) | 0.63 (0.24–1.65) | 0.34 | |
Neutropenia | 139 (26.53) | 46 (29.30) | 0.89 (0.67–1.19) | 0.44 | |
Skin abnormalities | Rash | 147 (28.05) | 46 (29.30) | 0.93 (0.71–1.23) | 0.63 |
Pruritus | 179 (34.16) | 49 (31.21) | 1.06 (0.81–1.38) | 0.67 | |
Alopecia | 116 (27.36) | 23 (21.70) | 1.06 (0.50–2.24) | 0.88 |