Study 203 (DB extension) 78 48 - 78(1) Study 203 (open extension) - - 79 79(1) Monotherapy Study 303 107 107 - 107 305 - - 143(1) 143(1) Study 202 (core period) 96 27 - 96 Study 202 (open extension) - - 50(1) 50(1) Total gout subjects 1799(2) TOTAL 1438 770 1183 2586(2) (1) A proportion of subjects had also received lesinurad in the preceding controlled study. (2) Unique subjects Adverse events An overall summary of the incidence of AEs in the pivotal studies 301, 302 and 304 is shown in Table 15. Table 15. Studies 301, 302 and 304 Overall summary of AEs. – All adverse events (irrespective of relationship to study treatment) Pivotal studies (301, 302 and 304) The overall incidence of any AE was 77.7% with lesinurad and 70.3% with placebo. Common AEs (those occurring with an incidence of 2% in either lesinurad group) are summarised in ≥ Table 16. Comment: Creatinine increases were reported more frequently as AEs (6.1% with lesinurad vs. 2.3% with placebo). The incidence was dose related (4.3% at 200 mg vs. 7.8% at 400 mg). Blood urea increases were also more commonly reported with lesinurad (1.4% vs. 0.6%). Headache, dizziness and hypertension were also slightly more common with lesinurad. Table 16. Studies 301, 302 and 304 Common AEs (incidence 2%). – ≥ Most of the AEs were as mild or moderate in severity (Table 17). Table 17. Studies 301, 302 and 304 AEs by severity. –
Study 203 (DB extension) 78 48 - 78(1) Study 203 (open extension) - - 79 79(1) Monotherapy Study 303 107 107 - 107 305 - - 143(1) 143(1) Study 202 (core period) 96 27 - 96 Study 202 (open extension) - - 50(1) 50(1) Total gout subjects 1799(2) TOTAL 1438 770 1183 2586(2) (1) A proportion of subjects had also received lesinurad in the preceding controlled study. (2) Unique subjects Adverse events An overall summary of the incidence of AEs in the pivotal studies 301, 302 and 304 is shown in Table 15. Table 15. Studies 301, 302 and 304 – Overall summary of AEs. All adverse events (irrespective of relationship to study treatment) Pivotal studies (301, 302 and 304) The overall incidence of any AE was 77.7% with lesinurad and 70.3% with placebo. Common AEs (those occurring with an incidence of ≥ 2% in either lesinurad group) are summarised in Table 16. Comment: Creatinine increases were reported more frequently as AEs (6.1% with lesinurad vs. 2.3% with placebo). The incidence was dose related (4.3% at 200 mg vs. 7.8% at 400 mg). Blood urea increases were also more commonly reported with lesinurad (1.4% vs. 0.6%). Headache, dizziness and hypertension were also slightly more common with lesinurad. Table 16. Studies 301, 302 and 304 – Common AEs (incidence ≥ 2%). Most of the AEs were as mild or moderate in severity (Table 17). Table 17. Studies 301, 302 and 304 – AEs by severity.
auspar-lesinurad-160920-cer.docx