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Results – Safety Data Through Week 12 (Study 1)<br />
Adverse events, n (%)<br />
Placebo<br />
n=50<br />
3 mg BID<br />
n=50<br />
6 mg BID<br />
n=50<br />
ABT-494<br />
12 mg BID<br />
n=50<br />
18 mg BID<br />
n=50<br />
24 mg QD<br />
n=49<br />
Any AE 13 (26) 20 (40) 23 (46) 29 (58) 25 (50) 17 (35)<br />
Any SAE 0 0 2 (4) 1 (2) 3 (6) 2 (4)<br />
Any AE leading to discontinuation 1 (2) 1 (2) 1 (2) 1 (2) 5 (10) 1 (2)<br />
AEs of special interest:<br />
Infection 7 (14) 10 (20) 7 (14) 12 (24) 11 (22) 9 (18)<br />
Serious infections 0 0 0 1 (2) 0 0<br />
Cardiovascular event 0 0 0 1 (2)† 0 0<br />
Herpes zoster* 0 1 (2) 0 0 0 2 (4)<br />
Hepatic disorder 0 1 (2) 0 0 2 (4) 0<br />
Malignancy 0 0 1 (2)‡ 0 0 0<br />
*Events involved 1 dermatome in each patient;†Lung cancer on posttreatment Day 10 in a 79-year-old man who had smoked for 40 years and had<br />
a family history of lung cancer; the patient died 3 months later; ‡Cerebrovascular accident adjudicated as an ishemic stroke.<br />
<strong>Genovese</strong> MC, et al. Arthritis Rheum 2016;68:2857–66.
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