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Aybintio · 4.8 · 14 a Terms represent a group of events that describe a medical concept rather than a single condition or MedDR
Eintrag öffnenAybintio · 4.8 · 15 Wound healing (see section 4.4) As bevacizumab may adversely impact wound healing, patients who had major s
Eintrag öffnenAybintio · 4.8 · 16 Across clinical trials, 8 cases of PRES have been reported. Two of the eight cases did not have radiologica
Eintrag öffnenAybintio · 4.8 · 17 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety a
Eintrag öffnenAybintio · 4.8 · 18 AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CH
Eintrag öffnenAybintio · 4.8 · 19 observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations
Eintrag öffnenAybintio · 4.8 · 20 System organ class Reactions (frequency*) (SOC) Vascular disorders Renal thrombotic microangiopathy with or
Eintrag öffnenAybintio · 4.8 · Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumab-treated patien
Eintrag öffnenAybintio · 4.8 · Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patie
Eintrag öffnenAybintio · 4.8 · Adverse reactions are added to the appropriate frequency category in the tables below according to the highest
Eintrag öffnenAybintio · 4.8 · An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large B- cell lym
Eintrag öffnenAybintio · 4.8 · Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizu
Eintrag öffnenAybintio · 4.8 · Bevacizumab is not approved for use in patients under the age of 18 years. In published literature reports, ca
Eintrag öffnenAybintio · 4.8 · Cardiac disorders Congestive heart failurea,b, Supraventricular tachycardia
Eintrag öffnenAybintio · 4.8 · Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baselin
Eintrag öffnenAybintio · 4.8 · Congestive heart failure (CHF) In clinical trials with bevacizumab, congestive heart failure (CHF) was observe
Eintrag öffnenAybintio · 4.8 · Description of selected serious adverse reactions
Eintrag öffnenAybintio · 4.8 · Dictionary for Regulatory Activities) preferred term. This group of medical terms may involve the same underly
Eintrag öffnenAybintio · 4.8 · Elderly patients In randomised clinical trials, age > 65 years was associated with an increased risk of develo
Eintrag öffnenAybintio · 4.8 · Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which r
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