Search results for "Interim"

Median progression free survival (PFS) for patients treated with everolimus (EVE) plus exemestane (EXE) for HR plus mBC in routine clinical practice …

2017

e12547 Background: BRAWO is a 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. We report updated data of the 3rd interim analysis, including PFS. Methods: This updated analysis (data cut-off 18 Oct 2016) covers data of the first 1345 documented pts with at least one follow up under therapy. Here we describe the baseline characteristics…

Adherence to ruxolitinib, an oral JAK1/2 inhibitor, in patients with myelofibrosis: interim analysis from an Italian, prospective cohort study (ROMEI…

2021

ROMEI, a prospective, observational study in patients with myelofibrosis receiving the oral JAK1/2 inhibitor ruxolitinib in real-world practice, assesses treatment adherence based on the 8-item Morisky Medication Adherence Scale (MMAS-8). Here, we present MMAS-8 results at week 24. Overall, 101 of 188 evaluable patients completed the questionnaire at every visit (full completers). Mean (±standard deviation) total MMAS-8 scores remained stable from week 4 to week 24 in the overall population (7.54 ± 0.77 and 7.67 ± 0.70, respectively) and full completers (7.53 ± 0.79 and 7.67 ± 0.73, respectively). Rates of low (MMAS-8 ˂6) or medium (MMAS-8 ≥ 6 to ˂8) adherence were 25–40% and 26–36%, respec…

742 EFFICACY AND SAFETY OF ENTECAVIR (ETV) PROPHYLAXIS IN INACTIVE HBV CARRIERS WHO UNDERWENT CHEMOTHERAPY FOR SOLID OR HAEMATOLOGICAL CANCER: INTERI…

2013

seroconversion rate at 48 weeks were 40.7% and 37% in PEG-IFN a-2a group, respectively, which are both higher than those in ETV group (16.7% and 13.3%, P all 0.05). The mean qHBsAg level in PEG-IFN a-2a group declined over time during treatment. The qHBsAg level at 48 weeks was significantly lower than that in ETV group ((2866.0±2580.4) vs (4335.8±2650.0) IU/mL, P = 0.027). A greater HBsAg decline was observed in HBeAg seroconverters compared with nonseroconverters. The decline from baseline was significantly different between seroconverters and non-seroconverters especially at 36 weeks ((1763.4±3116.2) vs (1333.5±2483.4) IU/mL, P = 0.036), and 48 weeks (1979.6±2897.1) vs (1631.8±2395.8) IU…

Improvement of analytical methods in post‐market monitoring of food additives and testing of the improved methods (OC/EFSA/DCM/2012/04): Interim repo…

2014

Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma…

2013

e17021 Background: This study investigates efficacy and toxicity of docetaxel added to cetuximab, cisplatin and 5-FU for patients with R/M SCCHN. We here report a planned second interim analysis to compare response rates between arms in order to decide on continuing to full accrual. Methods: Inclusion criteria were: stage III/IV R/M SCCHN and ECOG 0-1. Patients were randomized to arm A: cetuximab (standard dose) plus a maximum of 6 cycles of docetaxel (40 mg/m², day 1+8), cisplatin (40 mg/m², day 1+8) and 5-FU (2000 mg/m², day 1+8) or to arm B: cetuximab (standard dose), cisplatin (100 mg/m², day 1) and 5-FU (1000 mg/m², day 1-4). Treatment was administered until progression or intolerabil…

Interim 18f-PDGPET for Aggressive Non-Hodgking's Lymphoma: A Systematic Review and Meta-Analysis

2011

Abstract Abstract 5183 Background: The advantage of using interim 18F-fluorodeoxyglucose (FDG) positron-emission tomography (PET) scan in the clinical work-up of patients with non-Hodgkin's lymphoma (NLH) is unclear. Data from meta-analyses are inconclusive, mainly because of the low number of patients evaluated and heterogeneity among studies. New clinical investigations, focused on this topic, have been recently published. We conducted an updated systematic review on the role of 18PDG-PET for the interim evaluation in patients with aggressive lymphomas. Materials and Methods: Medline, Embase, Scopus and Databases were searched for relevant studies through March 2011. We included studies t…

Investor Protection and Business Creation

2003

We study the effects of investor protection on the availability of external finance, entrepreneurship, and creation of new firms in an equilibrium search model of private capital markets. In addition to search frictions, we examine contract frictions, specifically interim and ex post moral hazard problems stemming from entrepreneurs' possibilities to expropriate financiers. In our model, the government chooses the level of investor protection that determines the transferability of match surplus between entrepreneurs and financiers. The results indicate that anything that increases (decreases) entrepreneurship also increases (decreases) the creation of start-ups. The effect of investor prote…

The EU-Africa Trade Agreements

2021

This chapter scrutinizes the successive rounds of EU-Africa agreements and the four-tier preference system of the European Union for developing countries, with special attention to the Economic Partnership Agreements (EPA). Full EPAs and interim EPAs are reviewed in terms of the resulting country configurations in Africa and their impact on the officially intended consolidation of African regional communities. The analysis concludes that the artificial EPA configurations do not correspond to any existing REC in Africa. If they last, they will have a very critical effect on Africa’s regional economic integration, all the more as they start to be emulated in other trade agreements between Afr…

Opening the Door for the Opportunistic Use of Interim Financing: A Critical Assessment of the EU Draft Directive on Preventive Restructuring Framewor…

2018

The draft of the EU Directive on Preventive Restructuring Frameworks and Second Chance (the "Directive") provides rules for adopting reorganisation plans in order to avoid insolvency. The draft Directive also provides rules on the related problem of interim financing. According to the draft Directive, interim financing should be encouraged and not be made subject to clawback unless parties have committed fraud or acted in bad faith. The Directive thereby fails to recognise that finance transactions are too diverse in nature to provide the company and its financial creditors with a transaction avoidance free period. If the Directive is adopted in its current form, it will open the door for o…

Interim Report on Survey of Teaching Practices In Developing Countries

2013

This paper illustrates a research method appropriate for researchers examining teaching practices and teacher training in poor countries. The method of research described here does not compare with large scale studies in terms of sample size, scientific rigor, and sophisticated statistical analysis. We believe, however, that it can, provide valid information sufficient in accuracy for policy making. Most importantly, we believe, this method offers a feasible way for national researchers to explore why teachers teach as they do in their country. A fundamental assumption is that once in the classroom most teachers learn little more about teaching. In the absence of any systematic feedback or …