Examples of using Single-arm study in English and their translations into German
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CRYSTAL was a single-arm study with 0.5 mg ranibizumab monotherapy.
There was one ALK-positive patient>85 years old out of 154 patients in single-arm Study 1001 see also section 4.2 and 5.2.
Study 1 was a single-arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm study of 154 patients with the primary endpoint of objective response rate ORR.
AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected with HIV.
The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies(Studies 1007 and 1014) and in 2 single-arm studies(Studies 1001 and 1005),and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients see section 5.1.
BRF113710(BREAK-2) was a multicentre, single-arm study that enrolled 92 subjects with metastatic melanoma(Stage IV) with confirmed BRAF V600E or V600K mutation-positive melanoma.
Title A Phase 1/2 single-arm study evaluating the safety and efficacy of eribulin mesilate in combination with irinotecan in children with refractory or recurrent solid tumors.
About the TrialThis Phase II, multicenter, open-label, single-arm study of regorafenib enrolled 49 previously untreated patients with metastatic or unresectable, predominantly clear-cell RCC.
In a single-arm study of Herceptin as a single agent no relapsed metastatic breast cancer, the overall response rate in 173 patients with FISH positive tumors tested was 19%, whereas no objective responses were observed in patients with FISH(-) tumors.
Initial treatment, weekly for 8 doses In a multi-centre, single-arm study, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/ m2 of MabThera as intravenous infusion weekly for eight doses.
In a single-arm study including 36 patients with malignant glioma, drug-related adverse events were reported in 4 patients one patient: mild diarrhoea, one patient: moderate hypesthesia, one patient: moderate chills, and one patient: arterial hypotension 30 minutes after application of 5-ALA HCl.
LAL-CL03 was a multicentre, open-label, single-arm study of KANUMA in 9 patients with LAL deficiency with growth failure or other evidence of rapidly progressive disease prior to 6 months of age.
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced(metastatic or locally recurrent) breast cancer.
NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 1, 4, 5 or 6 HCV infection.
Re-treatment, weekly for 4 doses In a multi-centre, single-arm study, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of MabThera, were re- treated with 375 mg/ m2 of MabThera as intravenous infusion weekly for four doses.
Single-arm studies in ALK-positive advanced NSCLC.
Based on available data from patientsreceiving cinacalcet in placebo controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
On anthroposophic preparations 30 prospective randomised controlled trials, 18 non-randomised prospective comparative studies, 42 retrospective comparative studies, and 40 single-arm studies are available.
The use of single-agent crizotinib in the treatment of ALK-positive advancedNSCLC was investigated in 2 multinational, single-arm studies Studies 1001 and 1005.
Adverse reactions, considered at least possibly attributable tocinacalcet treatment in the placebo controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common(≥ 1/10); common(≥ 1/100 to< 1/10); uncommon(≥ 1/1,000 to< 1/100); rare(≥ 1/10,000 to< 1/1,000); very rare(< 1/10,000); not known cannot be estimated from the available data.
The use of Zykadia in the treatment of ALK-positive NSCLC patients previously treated with an ALK inhibitor was investigated in two global, multicentre,open-label, single-arm studies Study A and Study B.
BUELACH, Switzerland, May 23rd, 2012- The six-month results from theprospective, multicenter, single-arm 4EVER study demonstrate efficacy and safety of BIOTRONIK's Pulsar Stent System in 120 superficial femoral artery(SFA) patients.