Table 4. Summary of Safety Results through Week 44 of the IM-UNITI Study.
| Description | Placebo | 90 mg SC q12w | 90 mg SC q8w | Combined | ||||
|---|---|---|---|---|---|---|---|---|
| Japan (n=4) | All (n=133) | Japan (n=8) | All (n=132) | Japan (n=9) | All (n=131) | Japan (n=17) | All (n=263) | |
| Average duration of follow-up (wk) | 30.2 | 32.0 | 39.3 | 36.6 | 36.0 | 35.2 | 37.6 | 35.9 |
| TEAE | 4 (100.0) | 111 (83.5) | 8 (100.0) | 106 (80.3) | 8 (88.9) | 107 (81.7) | 16 (94.1) | 213 (81.0) |
| Serious TEAE | 0 | 20 (15.0) | 2 (25.0) | 16 (12.1) | 1 (11.1) | 13 (9.9) | 3 (17.6) | 29 (11.0) |
| Infectiona | 2 (50.0) | 66 (49.6) | 5 (62.5) | 61 (46.2) | 8 (88.9) | 63 (48.1) | 13 (76.5) | 124 (47.1) |
| Serious infectiona | 0 | 3 (2.3) | 2 (25.0) | 7 (5.3) | 0 | 3 (2.3) | 2 (11.8) | 10 (3.8) |
| TEAEs leading to discontinuation of study drug | 0 | 8 (6.0) | 1 (12.5) | 10 (7.6) | 0 | 4 (3.1) | 1 (5.9) | 14 (5.3) |
Values are presented as number (%).
aInfection as assessed by the investigator
q12w, every 12 weeks; q8w, every 8 weeks; TEAE, treatment-emergent adverse event.