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Yervoy · 4.8 · 29 from onset to resolution of 4 weeks (range 0.6 to 22 weeks). In clinical trials, immune-related colitis was
Eintrag öffnenYervoy · 4.8 · 30 moderate (Grade 2) and responsive to symptomatic therapy. The median time to onset of moderate to severe or
Eintrag öffnenYervoy · 4.8 · 31 Immunogenicity Less than 2% of patients with advanced melanoma who received ipilimumab in Phase 2 and 3 cli
Eintrag öffnenYervoy · 4.8 · 32 In study CA184178, no new or unexpected irARs were observed, and the observed irARs were similar in frequen
Eintrag öffnenYervoy · 4.8 · 33 No new safety signals were observed in clinical study CA209908 of 74 paediatric patients with high-grade pr
Eintrag öffnenYervoy · 4.8 · A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table
Eintrag öffnenYervoy · 4.8 · AEs leading to study drug 0 3 ( 37.5) 2 ( 22.2) 1 (25.0) 5 (62.5) 12 (10.8) 88 (27.1) discontinuation, n (%)
Eintrag öffnenYervoy · 4.8 · Advanced melanoma and non- Advanced melanoma Advanced melanoma melanoma solid tumours
Eintrag öffnenYervoy · 4.8 · Adverse reactions reported in patients with advanced melanoma who were treated with ipilimumab 3 mg/kg in clin
Eintrag öffnenYervoy · 4.8 · Adverse reactions reported in the pooled dataset for patients treated with ipilimumab in combination with nivo
Eintrag öffnenYervoy · 4.8 · Age ≥ 12 to 21 years Age 12 to < 18 years Adults
Eintrag öffnenYervoy · 4.8 · All deaths, n (%) 1 (100.0) 4 (50.0) 2 (22.2) 2 (50.0) 3 (37.5) 26 (23.4) 71 (21.8)
Eintrag öffnenYervoy · 4.8 · Among patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg for melanoma, a higher pr
Eintrag öffnenYervoy · 4.8 · CA184004/ CA184004/ 007/008/022 CA184070 CA184178 022 pooled pooled
Eintrag öffnenYervoy · 4.8 · Drug-related AEs leading to study drug 0 3 ( 37.5) 2 ( 22.2) 1 (25.0) 5 (62.5) 9 (8.1) 61 (18.8) discontinuati
Eintrag öffnenYervoy · 4.8 · Drug-related AEs, n (%) 1 (100.0) 7 ( 87.5) 9 (100.0) 2 (50.0) 7 (87.5) 88 (79.3) 274 (84.3) MedDRA v.17.0 for
Eintrag öffnenYervoy · 4.8 · Except where noted, data relating to ipilimumab monotherapy are based on patients who received either ipilimum
Eintrag öffnenYervoy · 4.8 · Immune-related colitis In patients treated with ipilimumab in combination with nivolumab (with or without chem
Eintrag öffnenYervoy · 4.8 · Immune-related endocrinopathy In the ipilimumab 3 mg/kg monotherapy group, hypopituitarism of any severity was
Eintrag öffnenYervoy · 4.8 · Immune-related gastrointestinal reactions Ipilimumab is associated with serious immune-related gastrointestina
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