Examples of using Randomised phase in English and their translations into Hungarian
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Randomised phase 3 study vs. dacarbazine(CA209066).
Previously untreated ALK-positive advanced NSCLC- randomised Phase 3 Study 1014.
Randomised phase 3 study vs. chemotherapy(CA209037).
Previously treated ALK-positive advanced NSCLC- randomised Phase 3 Study 1007.
Randomised phase 3 study of nivolumab in combination with ipilimumab or nivolumab as monotherapy vs. ipilimumab as monotherapy(CA209067).
Table 4 Adverse reactions occurring in the two randomised Phase III combination studies MEK115306(n=209) and MEK116513a(n=350).
Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than inpatients treated with comparators in pooled comparative randomised phase 3 studies.
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.
Two randomised phase 3 studies(COMFORT-I and COMFORT-II) were conducted in patients with MF(primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis).
The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial(HPV-015) that included a total of 5777 women aged 26 years and older.
A randomised Phase III study(EGF111438)(N=540) compared the effect of the two regimens on the incidence of CNS as site of first relapse in women with HER2 overexpressing metastatic breast cancer.
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).
Non-haematological adverse reactions(excluding laboratory abnormalities) that are reported in at least 5% of the patients treated with300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 2.
Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
During the 6-month randomised phase of study GS-US-205-0110, treatment-emergent isolation of MSSA and MRSA was observed more commonly among aztreonam-treated patients than Tobramycin Nebuliser Solution(TNS)-treated 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.
An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of VELCADE in patients with previously treated light-chain(AL) Amyloidosis.
Patients participating in this study in Europe who completed at least 1 course of Cayston orTNS during the randomised phase could subsequently receive up to three 28-day courses of Cayston in an open-label extension phase. .
Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and overall survival(OS) are shown in Figure 1 and 2, respectively.
Table 3 presents adverse reactions reported in 1722 patients with either ALK-positive orROS1-positive advanced NSCLC who received crizotinib across 2 randomised Phase 3 studies(1007 and 1014) and 2 single-arm clinical studies(1001 and 1005)(see section 5.1).
An open-label, multicentre, international, randomised phase III study supports the use of vemurafenib in previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients(from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort,non- randomised phase III trial, and were treated with Glivec(340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
The randomised phase 3 trial(0201) compared Ceplene+IL-2 treatment to no treatment in 261 patients in first remission(CR1) and in another 59 patients in subsequent remission after relapse(CR> 1).
Adverse drug reactions(ADR)data obtained from 323 patients with metastatic breast cancer in three randomised phase III trials of Myocet as a single agent and in combination with Cyclophosphamide(CPA) have been provided in Table 1 as pooled data.
In a randomised phase III study of 126 patients with advanced or metastatic pancreatic cancer, gemcitabine showed a statistically significant higher clinical benefit response rate than 5-fluorouracil(23.8% and 4.8% respectively, p=0.0022).
The efficacy of Perjeta inHER2-positive breast cancer is supported by a randomised phase III comparative trial in metastatic breast cancer and two phase II studies(one single-arm trial in metastatic breast cancer and one randomised comparative trial in the neoadjuvant setting).
In a randomised phase III study, 356 patients with advanced epithelial ovarian carcinoma who had relapsed at least 6 months after completing platinum-based therapy were randomised to therapy with gemcitabine and carboplatin(GCb), or carboplatin(Cb).
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. .
In another randomised phase III trial which compared intravenous topotecan to cyclophosphamide, Adriamycin(doxorubicin) and vincristine(CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group.