Search results for "Non interventional"
showing 8 items of 8 documents
Analysis of everolimus starting dose as prognostic marker in HR+ mBC patients treated with everolimus (EVE) + exemestane (EXE): Results of the 3rd in…
2017
1061 Background: BRAWO is a German non-interventional study, which enrolled more than 2400 patients (pts) with advanced/metastatic, hormone-receptor-positive and HER2-negative breast cancer treated with EVE and EXE. Main objectives are a) the impact of physical activity on efficacy and quality of life, b) prophylaxis and management of stomatitis in clinical routine, and c) the sequence of therapy when EVE is used in daily clinical practice. Methods: In this update on the results of the 3rd interim analysis (data cut-off 18-Oct-2016) we analyzed under real world conditions the first 1.078 patients followed up until disease progression for their progression-free survival (PFS) events. A two-…
Patient Expectations in the Treatment of Painful Diabetic Polyneuropathy: Results from a Non-Interventional Study
2014
Objective Pain control is the main objective when treating patients with painful diabetic peripheral neuropathic pain (DPNP). However, DPNP is associated with further substantial patient burden that often is not appropriately addressed. Our study identified patients' needs and asked patients what they expected from DPNP treatment. Methods Baseline data were collected in a German prospective, non-interventional study in patients with DPNP starting or switching pain medication at the discretion of the investigator. DPNP severity was evaluated using Brief Pain Inventory (BPI) and Clinician/Patient Global Impression-Severity (CGI-S/PGI-S). Primary objective of this study was to evaluate for whi…
Encorafenib plus Binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma: First data of the multicenter, m…
2021
9555 Background: For the treatment of advanced BRAFV600-mutated melanoma, targeted therapy (BRAF/MEK-inhibition) is a standard of care. Encorafenib + binimetinib (EB) were approved in the EU in Sep 2018 and in Switzerland in Nov 2019, based on positive results from COLUMBUS (NCT01909453), with a median progression-free survival (PFS) of 14.9 mo (4-year PFS: 26%) and overall survival (OS) of 33.6 mo (4-year OS: 39%). As data from controlled trials are based on selected populations, BERINGMELANOMA investigates the use of EB under real-world conditions in a broader population. Methods: BERINGMELANOMA is an ongoing, multi-national, multi-center, prospective, longitudinal, non-interventional st…
Subcutaneous trastuzumab therapy for HER2-positive early breast cancer in the routine clinical practice: First interim analysis of the National Non-I…
2016
581Background: In 2013 a subcutaneous (SC) formulation of trastuzumab (T) was approved based on non-inferiority to intravenous (IV) T as proven in the HannaH trial. So far no data from the routine ...
MON-445 Long-Term Results of an Ongoing Non-Interventional, Real-World Observational Study of Pasireotide SC in Cushing's Disease
2019
Abstract Background: Clinical trials have shown that subcutaneous (sc) pasireotide effectively decreases urinary free cortisol (UFC), improves signs/symptoms and has a favorable safety profile in patients with Cushing’s disease (CD). We describe interim long-term safety and efficacy results of an ongoing multicenter observational study of pasireotide sc in real-world clinical practice for CD (NCT02310269). Methods: This study aims to enroll 100-200 adults with CD for whom surgery has failed or is not an option. Eligible patients could have started pasireotide before (prior use) or at (new use) study entry. Primary endpoint: incidence of pasireotide-related adverse events (AEs) and serious A…
Final Evaluation Of a Prospective, Non-Interventional Study On Efficacy and Tolerability Of a New Generation VWF/FVIII Concentrate In The Treatment O…
2013
Background With marketing authorization in 2005, a non-interventional study (SET = Surveillance of Efficacy and Tolerability) with a double virus inactivated VWF/FVIII concentrate (Wilate®) was initiated in Germany. In 2012, the inclusion of patient documentation was terminated for final evaluation of the study data, representing the treatment of 170 patients suffering from von Willebrand’s disease (VWD). Aim The presented study was performed to assess the haemostatic efficacy and safety of a newly introduced VWF/FVIII product in the treatment of all types of VWD patients in every day clinical setting and to validate the results from pivotal clinical trials. Methods Patients of any age suf…
P141 2-year follow-up of COPD patients in the non-interventional ‘real-life’ daccord study in germany
2016
Introduction Although randomised, controlled trials are important in the development of new pharmacological treatments, they provide limited information on the ‘real life’ management of chronic diseases. Here, we analysed two-year follow-up data from the prospective, non-interventional, observational DACCORD study to evaluate the frequency of exacerbations and the evolution of disease severity using GOLD 2011 categorization. Methods COPD out-patients were recruited into DACCORD following either a change or initiation of COPD maintenance medication and followed up for 2 years. Data of 3137 patients that completed the 2-year follow-up were analysed; Exacerbation data were collected from the 6…
Factors Associated with Decisions for Initial Dosing, Up-Titration of Propiverine and Treatment Outcomes in Overactive Bladder Syndrome Patients in a…
2021
Two doses of propiverine ER (30 and 45 mg/d) are available for the treatment of overactive bladder (OAB) syndrome. We have explored factors associated with the initial dosing choice (allocation bias), the decision to adapt dosing (escalation bias) and how dosing relative to other factors affects treatment outcomes. Data from two non-interventional studies of 1335 and 745 OAB patients, respectively, receiving treatment with propiverine, were analyzed post-hoc. Multivariate analysis was applied to identify factors associated with dosing decisions and treatment outcomes. Several parameters were associated with dose choice, escalation to higher dose or treatment outcomes, but only few exhibited…