Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Calquence

Calquence 100 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17–18

HOS-146042 · Präparat HOS-099443

17  Calquence + Calquence + Calquence + Calquence + BR venetoclax venetoclax + Obinutuzumab N=297 N=291 obinutuzumab N=223 N=284 Grade Grade Grade Grade MedDRA SOC and All Grades All Grades All Grades All Grades ≥ 3* ≥ 3* ≥ 3* ≥ 3* MedDRA Term (%) (%) (%) (%) (%) (%) (%) (%) Very Very Very Very Platelets decreased§ common 10.8 common 17.8 common 5.2 common 13.7 (46.2) (69.4) (42.6) (54.9) Very Very Very Very Haemoglobin common 9 common 10.8 common 6.5 common 3.5 decreased§ (43.9) (79.5) (34.7) (45.8) Alanine Common aminotransferase - - 4.4 - - - - (9.1) increased‡ Aspartate Common aminotransferase - - 3.0 - - - - (8.1) increased‡ * Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. † Includes multiple ADR terms. ± One event with fatal outcome was reported. § Represents the incidence of laboratory findings, not of reported adverse events. ¶ Presented as CTCAE grade values. ‡ Adverse reaction only for the Calquence + BR arm in the ECHO study.

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