Hypophysitis 9 (2.0%) 64 (14.1%) Discontinuation study therapy 0 23 Immune-modulating medication 5 56 Hypothyroidism/thyroiditis 63 (13.9%) 41 (9.1%) Discontinuation study therapy 1 4 Immune-modulating medication 4 6 Hyperthyroidism 39 (8.6%) 22 (4.9%) Discontinuation study therapy 1 1 Immune-modulating medication 6 4 Diabetes mellitus 4(0.9%) 8 (1.8%) Discontinuation study therapy 0 0 Immune-modulating medication 0 0 Table 33: Non-endocrine IMAEs PT: subjects with event (%) Nivolumab 3mg/kg Ipilimumab 10 mg/kg Diarrhoea/colitis 174 (38.5%) 263 (51.8%) (immune-modulating medication) 29(6.4%) 144 (31.8%) Discontinuation study therapy 9 79 Hepatitis total 54 (11.9%) 119 (26.3%) IMAES (immune-modulating medication) 15 (3.3%) 43 (9.5%) Discontinuation study therapy 3 23 Pneumonitis total 8 (1.8%) 14 (3.1%) IMAES (immune-modulating medication) 8 (1.8%) 12 (2.6%) Discontinuation study therapy 2 7 Nephritis and renal dysfunction total 17 (3.8%) 19 (4.2%) IMAES (immune-modulating medication) 3 (0.7%) 1 (0.2%) Discontinuation therapy 0 0 Rash total 159 (35.2%) 215 (47.5%) IMAES (immune-modulating medication) 73 (16.2%) 105 (23.2%) Discontinuation study therapy 2 7 Hypersensitivity/infusion reactions total 13 (2.9%) 10 (2.2%) IMAES (immune-modulating medication) 1 (0.2%) 2 (0.4%) Discontinuation study therapy 0 0
Hypophysitis Discontinuation study therapy Immune-modulating medication 9 (2.0%) 0 5 64 (14.1%) 23 56 Hypothyroidism/thyroiditis Discontinuation study therapy Immune-modulating medication 63 (13.9%) 1 4 41 (9.1%) 4 6 Hyperthyroidism Discontinuation study therapy Immune-modulating medication 39 (8.6%) 1 6 22 (4.9%) 1 4 Diabetes mellitus Discontinuation study therapy Immune-modulating medication 4(0.9%) 0 0 8 (1.8%) 0 0 Table 33: Non-endocrine IMAEs PT: subjects with event (%) Nivolumab 3mg/kg Ipilimumab 10 mg/kg Diarrhoea/colitis (immune-modulating medication) Discontinuation study therapy 174 (38.5%) 29(6.4%) 9 263 (51.8%) 144 (31.8%) 79 Hepatitis total IMAES (immune-modulating medication) Discontinuation study therapy 54 (11.9%) 15 (3.3%) 3 119 (26.3%) 43 (9.5%) 23 Pneumonitis total IMAES (immune-modulating medication) Discontinuation study therapy 8 (1.8%) 8 (1.8%) 2 14 (3.1%) 12 (2.6%) 7 Nephritis and renal dysfunction total IMAES (immune-modulating medication) Discontinuation therapy 17 (3.8%) 3 (0.7%) 0 19 (4.2%) 1 (0.2%) 0 Rash total IMAES (immune-modulating medication) Discontinuation study therapy 159 (35.2%) 73 (16.2%) 2 215 (47.5%) 105 (23.2%) 7 Hypersensitivity/infusion reactions total IMAES (immune-modulating medication) Discontinuation study therapy 13 (2.9%) 1 (0.2%) 0 10 (2.2%) 2 (0.4%) 0