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. 2018 May 24;103(8):2949–2957. doi: 10.1210/jc.2018-00163

Table 2.

Treatment-Emergent AEs in ACTIVExtend, Cumulative Mo 19 to 43

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)