Примери за използване на Randomised phase на Английски и техните преводи на Български
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Randomised phase 3 study vs. docetaxel(CA209017).
The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Randomised Phase 3 Study MONARCH 3: Verzenios in combination with aromatase inhibitors.
Nonetheless, the CHMP noted that the pattern of adverse events in the randomised phase of this stidy was similar to that seen in the short-term studies.
Severe rash occurred in 1.4% and0.2% of the Viramune immediate-release and Viramune prolonged-release groups respectively during the randomised phase.
Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole+ lithium; aripiprazole+ valproate; placebo+ lithium; placebo+ valproate.
In the randomised phase IIb study(C208, stage 2) a higher rate of deaths was seen in the SIRTURO treatment group(12.7%; 10/79 patients) compared to the placebo treatment group(3.7%; 3/81 patients).
The efficacy of Cervarix was assessed in two controlled,double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy(ADT)in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study(CHAARTED).
Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions(excluding laboratory abnormalities)that are reported in at least 5% of the adult patients treated with 300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 3.
The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial(HPV-015) that included a total of 5778 women aged 26-72 years(median: 37.0 years).
TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer(T2-4d; primary tumour> 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
IntronA alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C.
Mean changes at week 48(end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Clinical efficacy in women aged 26 years and older The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial(HPV-015) that included a total of 5,778 women aged 26-72 years(median: 37.0 years).
Mean changes at week 48(end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Comparable withdrawal rates, including discontinuation due to adverse events,were also observed in an open label, randomised phase II study comparing Seasonique(34.5%) to two 28-day OC(35.2% and 39.1%) in 265 women for 8 months.
The data described below reflect exposure to Tasigna in a total of 717 patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily(n=279) and from an open-label multicentre Phase II study in patients with imatinib-resistant or intolerant CML in chronic phase(n=321) and accelerated phase(n=137) treated at the recommended dose of 400 mg twice daily.
Data from 106 patients accrued in two single-arm open-label studies andfrom 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
IntronA alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C. The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
The efficacy of Silgard in 16- through 26-year-old women was assessed in 4 placebo-controlled,double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Lartruvo was authorised based on a single open-label, randomised phase 1b/2 clinical trial which enrolled doxorubicin-naïve subjects with advanced soft tissue sarcoma not amenable to treatment with surgery and radiotherapy(study JGDG).
The data described below reflect exposure to Tasigna in 279 patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated with 300 mg of nilotinib twice daily.
Clinical studies in newly diagnosed CML in chronic phase An open-label, multicentre, randomised Phase III study was conducted to determine the efficacy of nilotinib versus imatinib in 846 adult patients with cytogenetically confirmed newly diagnosed Philadelphia chromosome positive CML in the chronic phase. .
The efficacy of Silgard in 16- through 26-year-old men was assessed in 1 placebo-controlled,doubleblind, randomised Phase III clinical study(Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
The data described below reflect exposure to nilotinib in a total of 737 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily(n=279) and from an open-label multicentre Phase II study in adult patients with imatinib-resistant or intolerant CML in chronic phase(n=321) and accelerated phase(n=137) treated at the recommended dose of 400 mg twice daily.
The efficacy of Silgard in 24- through 45-year-old women was assessed in 1 placebo-controlled,double-blind, randomised Phase III clinical study(Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.