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Vegzelma · 4.8 · 14 c For further information please refer to Table 3 'Adverse reactions reported in post-marketing setting.' d
Eintrag öffnenVegzelma · 4.8 · 15 surgery 28-60 days prior to starting bevacizumab. An increased incidence of post-operative bleeding or woun
Eintrag öffnenVegzelma · 4.8 · 16 In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving b
Eintrag öffnenVegzelma · 4.8 · 17 Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumab-treated pat
Eintrag öffnenVegzelma · 4.8 · 18 combination with chemotherapy compared with up to 0.9% in the control arms. For patients in study AVF3694g
Eintrag öffnenVegzelma · 4.8 · 19 Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times base
Eintrag öffnenVegzelma · 4.8 · 20 System organ class Reactions (frequency*) (SOC) Nervous system Hypertensive encephalopathy (very rare) (see
Eintrag öffnenVegzelma · 4.8 · Across clinical trials, 8 cases of PRES have been reported. Two of the eight cases did not have radiological c
Eintrag öffnenVegzelma · 4.8 · Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patie
Eintrag öffnenVegzelma · 4.8 · Adverse reactions are added to the appropriate frequency category in the tables below according to the highest
Eintrag öffnenVegzelma · 4.8 · An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large B-cell lymp
Eintrag öffnenVegzelma · 4.8 · Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizu
Eintrag öffnenVegzelma · 4.8 · Anaphylactic shock (rare) (see also section 4.4)
Eintrag öffnenVegzelma · 4.8 · Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients
Eintrag öffnenVegzelma · 4.8 · Congestive heart failure (CHF) In clinical trials with bevacizumab, CHF was observed in all cancer indications
Eintrag öffnenVegzelma · 4.8 · Description of selected serious adverse reactions Gastrointestinal (GI) perforations and fistulae (see section
Eintrag öffnenVegzelma · 4.8 · Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which r
Eintrag öffnenVegzelma · 4.8 · From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-0240), 1.8% o
Eintrag öffnenVegzelma · 4.8 · From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240),
Eintrag öffnenVegzelma · 4.8 · From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240),
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