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Xgeva · 4.8 · Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe
Eintrag öffnenXgeva · 4.8 · Atypical fractures of the femur In the clinical trial programme overall, atypical femoral fractures have been
Eintrag öffnenXgeva · 4.8 · Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing
Eintrag öffnenXgeva · 4.8 · Description of selected adverse reactions
Eintrag öffnenXgeva · 4.8 · Drug related hypersensitivity reactions In the post-marketing setting, events of hypersensitivity, including r
Eintrag öffnenXgeva · 4.8 · Hypocalcaemia A higher incidence of hypocalcaemia among patients treated with denosumab compared to zoledronic
Eintrag öffnenXgeva · 4.8 · Hypocalcaemia has very commonly been reported following XGEVA administration, mostly within the first 2 weeks.
Eintrag öffnenXgeva · 4.8 · In a long-term phase II open-label clinical trial in patients with giant cell tumour of bone (study 6, see sec
Eintrag öffnenXgeva · 4.8 · In patients with giant cell tumour of bone, incidence of new malignancy, including malignancies involving the
Eintrag öffnenXgeva · 4.8 · In the clinical trial programme for GCTB, atypical femoral fractures have been reported commonly in patients t
Eintrag öffnenXgeva · 4.8 · In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported, wit
Eintrag öffnenXgeva · 4.8 · In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced
Eintrag öffnenXgeva · 4.8 · In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was repor
Eintrag öffnenXgeva · 4.8 · Lichenoid drug eruptions Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in p
Eintrag öffnenXgeva · 4.8 · MedDRA system Frequency category Adverse reactions organ class Neoplasms Common New primary benign, malignant
Eintrag öffnenXgeva · 4.8 · Musculoskeletal pain In the post-marketing setting, musculoskeletal pain, including severe cases, has been rep
Eintrag öffnenXgeva · 4.8 · New primary malignancy In the primary double-blind treatment phases of four phase III active-controlled clinic
Eintrag öffnenXgeva · 4.8 · No treatment-related pattern in individual cancers or cancer groupings was apparent.
Eintrag öffnenXgeva · 4.8 · Osteonecrosis of the jaw (ONJ) In clinical trials, the incidence of ONJ was higher with longer duration of exp
Eintrag öffnenXgeva · 4.8 · Other special populations
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