| (B) | Placebo (N=170) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Peficitinib 100 mg +150 mg (N=348) | Peficitinib total* (N=496) |
| Serious infections | |||||
| Patient-years | 62.9 | 159.5 | 160.8 | 320.3 | 407.8 |
| Number of patients who had at least one incidence | 0 | 6 | 6 | 12 | 14 |
| Incidence rate/100 patient-years (95% CI) | 0.0 | 3.8 (1.7, 8.4) | 3.7 (1.7, 8.3) | 3.7 (2.1, 6.6) | 3.4 (2.0, 5.8) |
| Herpes zoster-related disease (including varicella) | |||||
| Patient-years | 62.6 | 156.2 | 159.8 | 316.0 | 402.9 |
| Number of patients who had at least one incidence | 2 | 13 | 6 | 19 | 23 |
| Incidence rate/100 patient-years (95% CI) | 3.2 (0.8, 12.8) | 8.3 (4.8, 14.3) | 3.8 (1.7, 8.4) | 6.0 (3.8, 9.4) | 5.7 (3.8, 8.6) |
| Malignancies | |||||
| Patient-years | 62.9 | 162.2 | 163.0 | 325.2 | 413.2 |
| Number of patients who had at least one incidence | 1 | 1 | 0 | 1 | 1 |
| Incidence rate/100 patient-years (95% CI) | 1.6 (0.2, 11.3) | 0.6 (0.1, 4.4) | 0.0 | 0.3 (0.0, 2.2) | 0.2 (0.0, 1.7) |
Patient-years was calculated from initial dose up to first incidence of the event for patients who had at least one event, and from initial dose through follow-up for patients who had no events; incidence rate is calculated as (100 × number of patients who had at least one incidence/total patient-years).
*Including adverse events during treatment with peficitinib in patients who were initially treated with placebo and switched to peficitinib at week 12 or 28.
CI, confidence interval.