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Stivarga · 4.5 · UGT1A1 and UGT1A9 substrates In vitro data indicate that regorafenib as well as its active metabolite M-2 inhi
Eintrag öffnenStivarga · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenStivarga · 4.8 Undesirable effects · 1
Eintrag öffnenStivarga · 4.8 · 10 System Organ Class Very common Common Uncommon Rare Not known (MedDRA) Metabolism Decreased Hypo- and nutri
Eintrag öffnenStivarga · 4.8 · 11 System Organ Class Very common Common Uncommon Rare Not known (MedDRA) Musculo- Muscle skeletal and spasms
Eintrag öffnenStivarga · 4.8 · 13 Table 4: Treatment-emergent laboratory test abnormalities reported in placebo-controlled phase III trials i
Eintrag öffnenStivarga · 4.8 · 14 Compared to the global phase III CRC trial (CORRECT) with predominantly (~80%) Caucasian patients enrolled,
Eintrag öffnenStivarga · 4.8 · Bilirubin increased 66.7 7.4 4.4 32.8 4.5 0.0 AST increased 69.6 10.4 0.7 47.8 3.0 0.0 ALT increased 54.1 8.9
Eintrag öffnenStivarga · 4.8 · Description of selected adverse reactions In most cases of severe liver injury, liver dysfunction had an onset
Eintrag öffnenStivarga · 4.8 · In the placebo-controlled phase III trials, tests on thyroid stimulating hormone (TSH) showed post baseline >U
Eintrag öffnenStivarga · 4.8 · In the placebo-controlled phase III trials, the overall incidence of hand-foot skin reaction was higher in pat
Eintrag öffnenStivarga · 4.8 · In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients treat
Eintrag öffnenStivarga · 4.8 · In the placebo-controlled phase III trials, the overall incidence of treatment emergent proteinuria was 9.1% i
Eintrag öffnenStivarga · 4.8 · Laboratory test abnormalities Treatment-emergent laboratory abnormalities observed in the placebo-controlled p
Eintrag öffnenStivarga · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenStivarga · 4.8 · Stivarga plus BSC§ Placebo plus BSC§ (N=136) (N=68) Laboratory parameter, (in % of samples All Grade Grade All
Eintrag öffnenStivarga · 4.8 · Summary of the safety profile The overall safety profile of Stivarga is based on data from more than 4,800 tre
Eintrag öffnenStivarga · 4.8 · System Organ Class Very common Common Uncommon Rare Not known (MedDRA) Infections and Infection infestations *
Eintrag öffnenStivarga · 4.8 · Table 3: Adverse drug reactions (ADRs) reported in clinical trials and postmarketing in patients treated with
Eintrag öffnenStivarga · 4.8 · Table 4a: Treatment emergent liver enzyme test abnormalities reported in placebo-controlled phase III trial in
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