high risk first relapse of B-precursor ALL. Planned Studies Selected identified risks, Study 20150136: An Primary Objectives: 1) To Fourth quarter 2021 potential risks, and observational study of characterise the safety missing information as blinatumomab safety and profile of blinatumomab well as other serious effectiveness, utilisation, in routine clinical adverse events and treatment practices practice in countries in the EU. 2) To estimate the frequency and types of medication errors identified in patient charts. Secondary objectives: 1) To estimate the incidence of other serious adverse events, that is, serious adverse events not included in the primary objective. 2) To characterise safety and effectiveness endpoints among patient subgroups defined by demographic and clinical factors. 3) To characterise the effectiveness of blinatumomab in routine clinical practice. 4) To describe blinatumomab utilisation and healthcare resource use in routine clinical practice. Neurologic events, 20150163: Survey To evaluate the Second quarter 2019 medication errors. of physicians, distribution, knowledge pharmacists and nurses and impact on behaviour involved in the of additional risk prescribing, preparation minimisation measures and administration of for physicians, blinatumomab in Europe pharmacists and nurses. to evaluate the effectiveness of additional risk minimisation measures. Study 20150228: A cross Primary objective: To Third quarter 2018 sectional survey of assess knowledge about patients and caregivers and receipt of the receiving blinatumomab educational materials. in routine clinical Secondary objectives: practice in Europe to 1) To determine the evaluate the effectiveness level of understanding of additional risk of the information in minimisation the educational
high risk first relapse of B-precursor ALL. Planned Studies Selected identified risks, potential risks, and missing information as well as other serious adverse events Study 20150136: An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices Primary Objectives: 1) To characterise the safety profile of blinatumomab in routine clinical practice in countries in the EU. 2) To estimate the frequency and types of medication errors identified in patient charts. Secondary objectives: 1) To estimate the incidence of other serious adverse events, that is, serious adverse events not included in the primary objective. 2) To characterise safety and effectiveness endpoints among patient subgroups defined by demographic and clinical factors. 3) To characterise the effectiveness of blinatumomab in routine clinical practice. 4) To describe blinatumomab utilisation and healthcare resource use in routine clinical practice. Fourth quarter 2021 Neurologic events, medication errors. 20150163: Survey of physicians, pharmacists and nurses involved in the prescribing, preparation and administration of blinatumomab in Europe to evaluate the effectiveness of additional risk minimisation measures. To evaluate the distribution, knowledge and impact on behaviour of additional risk minimisation measures for physicians, pharmacists and nurses. Second quarter 2019 Study 20150228: A cross sectional survey of patients and caregivers receiving blinatumomab in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimisation Primary objective: To assess knowledge about and receipt of the educational materials. Secondary objectives: 1) To determine the level of understanding of the information in the educational Third quarter 2018
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