Примери за използване на Treated with stivarga на Английски и техните преводи на Български
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Patients treated with Stivarga lived on average for.
Adverse drug reactions(ADRs)reported in clinical trials in patients treated with Stivarga.
Avoid becoming pregnant while being treated with Stivarga, as this medicine may harm your unborn baby.
Gastrointestinal perforation(including fatal outcome) andfistulae have been reported in patients treated with Stivarga(see section 4.8).
The Asian patients treated with Stivarga in clinical studies were primarily from East Asia(~90%).
The adverse drug reactions reported in clinical trials in patients treated with Stivarga are shown in Table 3.
Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
In the placebo-controlled phase III trials, the overall incidence of haemorrhage was 18.2% in patients treated with Stivarga and 9.5% in patients receiving placebo.
Fatal outcome in patients treated with Stivarga was uncommon(0.7%), and included cerebral, respiratory, gastrointestinal and genitourinary events.
Or moderately impaired liver function while you are being treated with Stivarga, your doctor should monitor you closely.
Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.
TSH post baseline> 4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3% of patients receiving placebo.
Most cases of hypertension in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity(Grades 1 and 2: 20.9%, CRC, 31.8%, GIST and 15.8% HCC).
If you have a mildly ormoderately impaired liver function while you are being treated with Stivarga, your doctor should monitor you closely.
Most cases of hand-foot skin reaction in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity(Grades 1 and 2: 34.3%%, CRC, 44.7%, GIST and 39.3%, HCC).
Concentration of free thyroxin(FT4) post baseline<LLN was reported in 8.1% of patients treated with Stivarga and 5.6% of patients receiving placebo.
Most cases of bleeding events in patients treated with Stivarga were mild to moderate in severity(Grades 1 and 2: 15.2%), most notably epistaxis(6.1%).
The DCR(complete response or partial response or stable disease)was significantly higher in patients treated with Stivarga(41.0% vs. 14.9%, p< 0.000001, 1 sided).
Most infections in patients treated with Stivarga were mild to moderate in severity(Grades 1 and 2: 23.0%), and included urinary tract infections(5.7%), nasopharyngitis(4.0%), mucocutaneous and systemic fungal infections(3.3%) as well as pneumonia(2.6%).
In clinical trials, a higher incidence of HFSR was observed in Asian(in particular Japanese) patients treated with Stivarga, compared with Caucasians(see section 4.2).
If your liver function is severely impaired, you should not be treated with Stivarga, as there are no data on the use of Stivarga in patients with a severely impaired liver function.
Concentration of free triiodothyronine(FT3) post baseline below lower limit of normal(< LLN)was reported in 29.2% of patients treated with Stivarga and in 20.4% of patients receiving placebo.
Fatal outcomes associated with infection were observed more often in patients treated with Stivarga(1.0%), compared to patients receiving placebo(0.3%), and were mainly respiratory events.
In the placebo-controlled phase III trials, the overall incidence of treatment emergent proteinuria was 9.1% in patients treated with Stivarga, compared to 1.9% in patients receiving placebo.
In the placebo-controlled phase III trials, infections were more often observed in patients treated with Stivarga, compared to patients receiving placebo(all grades: 31.6% vs. 17.2%).
In clinical trials, a higher incidence of severe liver function test abnormalities andhepatic dysfunction was observed in Asian(in particular Japanese) patients treated with Stivarga, compared with Caucasians(see section 4.2).
The study showed that Stivarga increased the length oftime that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
In clinical trials,a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients(~1.5%) treated with Stivarga, compared with nonJapanese patients(< 0.1%).
In the placebo-controlled phase III trials,the overall incidence of hypertension was higher in patients treated with Stivarga, compared to patients receiving placebo(29.6% vs. 7.5% CRC, 60.6% vs. 25.8% GIST and 31.0% vs. 6.2% HCC).
In the placebo-controlled phase III trials, tests on thyroid stimulating hormone(TSH)showed post baseline> ULN in 34.6% of patients treated with Stivarga and in 17.2% of patients receiving placebo.