Table 2.
Summary of TEAEs, ACTIVExtend Safety Population (N = 1133) | PBO/ALN (n = 580), n (%) | ABL/ALN (n = 553), n (%) |
---|---|---|
≥1 TEAE | 466 (80.3) | 452 (81.7) |
≥1 Severe TEAE | 40 (6.9) | 38 (6.9) |
≥1 Serious TEAE | 58 (10.0) | 65 (11.8) |
≥1 TEAE leading to death | 2 (0.3) | 0 |
≥1 TEAE leading to discontinuation | 36 (6.2) | 30 (5.4) |
Most frequently (≥5% in either group) reported TEAEs | ||
Arthralgia | 58 (10.0) | 54 (9.8) |
Upper respiratory tract infection | 51 (8.8) | 40 (7.2) |
Back pain | 34 (5.9) | 36 (6.5) |
Hypertension | 33 (5.7) | 27 (4.9) |
Pain in extremity | 31 (5.3) | 23 (4.2) |
Osteoarthritis | 21 (3.6) | 28 (5.1) |