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Nexavar · 4.8 · Additional information on special populations In clinical trials, certain adverse drug reactions such as hand
Eintrag öffnenNexavar · 4.8 · Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in table
Eintrag öffnenNexavar · 4.8 · CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphope
Eintrag öffnenNexavar · 4.8 · Congestive heart failure In company sponsored clinical trials congestive heart failure was reported as an adve
Eintrag öffnenNexavar · 4.8 · Ear and tinnitus labyrinth disorders Cardiac congestive QT disorders heart failure* prolongation myocardial is
Eintrag öffnenNexavar · 4.8 · Hypocalcaemia was reported in 12% and 26.5% of sorafenib treated patients compared to 7.5% and 14.8% of placeb
Eintrag öffnenNexavar · 4.8 · Hypocalcaemia was reported in 35.7% of sorafenib treated patients compared to 11.0% of placebo patients. Most
Eintrag öffnenNexavar · 4.8 · Hypokalemia 17.9 1.9 0 2.4 0 0 Hypophosphatemia** 19.3 12.6 0 2.4 1.4 0 Hepatobiliary disorders Bilirubin incr
Eintrag öffnenNexavar · 4.8 · Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patient
Eintrag öffnenNexavar · 4.8 · In studies 1 and 3 decreased potassium was observed in 5.4% and 9.5% of sorafenib-treated patients compared to
Eintrag öffnenNexavar · 4.8 · Increased lipase and amylase were very commonly reported. CTCAE Grade 3 or 4 lipase elevations occurred in 11
Eintrag öffnenNexavar · 4.8 · Laboratory parameter, Sorafenib N=207 Placebo N=209 (in % of samples All Grade Grade All Grade Grade investiga
Eintrag öffnenNexavar · 4.8 · Laboratory test abnormalities in DTC patients (study 5)
Eintrag öffnenNexavar · 4.8 · Laboratory test abnormalities in HCC (study 3) and RCC (study 1) patients
Eintrag öffnenNexavar · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenNexavar · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenNexavar · 4.8 · System Very common Common Uncommon Rare Not known organ class Infections infection folliculitis and infestatio
Eintrag öffnenNexavar · 4.8 · Table 1: All adverse reactions reported in patients in multiple clinical trials or through post- marketing use
Eintrag öffnenNexavar · 4.8 · Table 2: Treatment-emergent laboratory test abnormalities reported in DTC patient (study 5) double blind perio
Eintrag öffnenNexavar · 4.8 · The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand foot skin reaction (corre
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