Nebenwirkungen · Keytruda
KEYTRUDA 395 mg solution for injection KEYTRUDA 790 mg solution for injection · Abschnitt 4.8 · PDF-Seite 182
HOS-131871 · Präparat HOS-097138
Immune-mediated colitis Colitis occurred in 158 (2.1%) patients, including Grade 2, 3 or 4 cases in 49 (0.6%), 82 (1.1%) and 6 (0.1%) patients, respectively, receiving pembrolizumab. The median time to onset of colitis was 4.3 months (range: 2 days to 24.3 months). The median duration was 1.1 month (range: 1 day to 45.2 months). Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. Colitis resolved in 132 patients, 2 with sequelae. In patients with CRC treated with pembrolizumab as monotherapy (n=153), the incidence of colitis was 6.5% (all Grades) with 2.0% Grade 3 and 1.3% Grade 4.
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Version 2026-07-01T16:10:00Z · SHA-256 e087d75948ee6d7e0436cc4d9426ed91824e992a89f4481a4ea0ddb3e3ee3588 · Passage 0eada487660807ded04bf690ae0efe50a14ea4ffd46ebc30dac896d0bc26f1ca · Zeichen 29099–29706 im Abschnitt