All SAEs 49.1 36.5 51.6 31.9 47.8 36.5 48.6 35.8 (regardless of causality) Drug-related 7.2 7.2 11.0 9.9 11.6 7.9 10.4 8.0 SAEs All AEs leading 12.6 3.0 24.2 13.2 17.7 11.1 17.3 9.3 to (regardless of causality) Drug-related 6.6 3.0 14.3 8.8 7.6 4.7 8.3 4.8 AEs leading to Deaths and other serious adverse events A summary of deaths and other SAEs from the dose ranging studies is given in Table 56, below. Table 56. Summary of deaths and SAEs in patients with advanced RCC receiving nivolumab monotherapy ID: CA902010* CA902009 CA902025 All RCC Patient % Patient % Patient % Patient % number number Patient number 167 91 406 664 Deaths 112 43.7 39 42.9 181 44.6 293 44.1 Within 30 days NA 4 4.4 19 4.7 23 3.5 Within 100 days NA 14 15.4 56 13.8 70 10.5 of death Due to Study Drug 0 0.0 0 0.0 0 0.0 0 0.0 Toxicity Due to disease 103 41.9 33 36.3 162 39.9 265 39.9 progression Unknown/other 9 1.8 6 6.6 19 4.7 28 4.2 SAEs
All SAEs (regardless of causality) 49.1 36.5 51.6 31.9 47.8 36.5 48.6 35.8 Drug-related SAEs 7.2 7.2 11.0 9.9 11.6 7.9 10.4 8.0 All AEs leading to (regardless of causality) 12.6 3.0 24.2 13.2 17.7 11.1 17.3 9.3 Drug-related AEs leading to 6.6 3.0 14.3 8.8 7.6 4.7 8.3 4.8 Deaths and other serious adverse events A summary of deaths and other SAEs from the dose ranging studies is given in Table 56, below. Table 56. Summary of deaths and SAEs in patients with advanced RCC receiving nivolumab monotherapy ID: CA902010* CA902009 CA902025 All RCC Patient % Patient number % Patient number % Patient % Patient number 167 91 406 664 Deaths 112 43.7 39 42.9 181 44.6 293 44.1 Within 30 days NA 4 4.4 19 4.7 23 3.5 Within 100 days NA 14 15.4 56 13.8 70 10.5 of death Due to Study Drug Toxicity 0 0.0 0 0.0 0 0.0 0 0.0 Due to disease progression 103 41.9 33 36.3 162 39.9 265 39.9 Unknown/other 9 1.8 6 6.6 19 4.7 28 4.2 SAEs
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