51 The Drug Rediscovery Protocol Extended Data Table 4. Adverse events in the first 215 patients (continued) Adverse event Grade 3 Grade 4 Grade 5 Pain 15 Partial paralysis 1 Peripheral sensory neuropathy 1 Pleural effusion 2 Pneumonia 3 Pneumonitis 1 Rectal perforation 1 Seizure 1 Skin rash or infection 5 Somnolence 1 Syncope 1 Tachycardia 1 Thromboembolic event 3 Urea ↑ 1 Vomiting 1 Extended Data Table 5. Adverse events in the MSI cohort All reported adverse events of grade 3 or higher that were (or could possibly be) attributed to treatment with nivolumab. Grades are given according to CTCAE version 4.03. a, For each adverse event, the number of patients is displayed in whom it was reported at grade 3, 4 or 5 as the highest grade. Upward-pointing arrows indicate an increase. b, The number of patients who had any grade 3 or higher, grade 4 or higher, or grade 5 or higher adverse event as their highest-grade adverse event is displayed. The denominator of the percentages is the total number of patients who started study treatment (n = 30 patients). Given that every patient could be counted only once per column in b, the numbers in b are not a summation of the numbers in a. A. Adverse event Grade 3 Grade 4 Grade 5 Abdominal infection 1 Abscess 1 Adrenal insufficiency 1 Alkaline phosphatase ↑ 1 Anal fistula 1 Anemia 1 Aspartate aminotransferase ↑ 1 Atrioventricular block 1 Dyspnea 1 Fatigue 2 Fever 1 2
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