Nebenwirkungen · Opdivo
OPDIVO 10 mg/mL concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 39–40
HOS-133397 · Präparat HOS-097426
39 (2/1800) of patients. Grade 2 and Grade 3 hypopituitarism occurred in 0.2% (4/1800) of patients, each. Grade 2, Grade 3, and Grade 4 adrenal insufficiency occurred in 0.6% (11/1800), 0.2% (3/1800), and < 0.1% (1/1800) of patients, respectively. One patient (< 0.1%) had a fatal outcome due to adrenal insufficiency. Diabetes mellitus including Type 1 diabetes mellitus, and fulminant Type 1 diabetes mellitus (4 Grade 2, 2 Grade 3, and 1 Grade 4), and diabetic ketoacidosis (1 Grade 2 and 1 Grade 4) were reported. Median time to onset of these endocrinopathies was 15.3 weeks (range: 1.1-124.3). Resolution occurred in 101 patients (40.1%). Time to resolution ranged from 0.3+ to 233.6+ weeks.
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Version 2026-08-19T11:11:00Z · SHA-256 1ce21ede7b3b9a8abc396626f301d2db3510ede7261a38fc34a275e7a180f454 · Passage 5a1705af744dae1deacaa5e66226e6c563d99f58525616ea575720af63029ad9 · Zeichen 56497–57195 im Abschnitt