Latest database descriptions

Cohort study in chronic kidney disease patients on dialysis starting treatment with Mircera® to correct anemia or maintain stable hemoglobin levels

August 23 2022

Primary objective: Describe the management of anemia treatment with Mircera® in routine clinical practice in chronic kidney disease patients on dialysis and to describe their hemoglobin concentration around the 6th month of treatment with Mircera®.

Secondary objective:
In the total population and in each sub-population of patients (hemodialysis and peritoneal dialysis, ESA-naive and non ESA-naive patients):
1. Describe the characteristics of patients treated with Mircera®;
2. Describe the evolution of Hb and hematocrit levels during the observation period;
3. Describe the biological parameters used to document renal anemia and any changes in values;
4. Describe the parameters influencing treatment response;
5. Describe the biological parameters reflecting the efficacy of dialysis;
6. Describe the safety profile of Mircera® (serious and/or unexpected adverse drug reactions and targeted adverse drug reactions related to Mircera®);
7. Describe treatment compliance with Mircera®;
8. Describe the evolution of patients’ quality of life, evaluated by the SF-36 questionnaire.

PharmacoEpidemiological study of the imPact of RoActemra® treatment on fatigue in rheumatoid arthritis patientS in a real life setting

August 23 2022

Primary objective: To describe in a real life setting the evolution of fatigue in patients with moderate to severe RA during the first 4 months of RoActemra® treatment, as well as to search for predictive factors of an improvement in this symptom.

Secondary objectives:
- To describe patient baseline characteristics and level of fatigue experienced at inclusion by the patient population treated with RoActemra®;
- To evaluate the correlation between the evolutions of fatigue as assessed by FACIT-Fatigue questionnaire and VAS fatigue during the first 4 months of RoActemra® treatment;
- To evaluate the time of onset of RoActemra® effect on fatigue in a real life setting;
- To assess the correlation between evolution of fatigue and disease activity during 4 months of RoActemra® treatment;
- To evaluate the PASS of the fatigue scales (FACIT-Fatigue, VAS fatigue, SF36 vitality) after 4 months of RoActemra® treatment;
- To evaluate the correlation between evolution of fatigue and other patient reported outcomes (PROs): pain, quality of sleep, disability, SF36 vitality, anxiety, depression;
- To describe the management of RA patients treated with RoActemra®;
- To describe all adverse events occurring during the study.

Descriptive epidemiological study of therapeutic decision-making during management of rheumatoid arthritis: physicians’ criteria and patients’ opinions

August 23 2022

Primary objectives: To describe the criteria used for therapeutic decision-making for RA patients:
- clinical, biological and radiological data, impact of RA on patients’ life according to physicians;
- impact of RA on patients’ life according to patients;
- physicians’ characteristics.

Secondary objectives:
- To describe the characteristics of the included patient population depending on treatment modifications after the inclusion visit.

Study of a patient cohort with locally advanced or metastatic non-small cell lung cancer treated with Tarceva® (Erlotinib) monotherapy and without progression after at least nine months

August 23 2022

Primary objective: To describe the progression-free survival of a population of patients with metastatic or locally advanced NSCLC treated with Tarceva® monotherapy whose disease has not progressed for at least nine months.

Secondary objectives:
- To describe patients’ characteristics at inclusion in the study and on initiation of treatment with Tarceva® monotherapy (demographic, clinical, and biological characteristics);
- To describe the use of Tarceva®;
- To evaluate the efficacy of treatment with Tarceva®: the best response obtained (complete response, partial response, or stabilisation), overall survival, and prognostic criteria for long-term survival on Tarceva®;
- To describe the long-term safety profile of Tarceva®;
- To describe the correlations between tumour biology and response to Tarceva®;
- To describe patient adherence to Tarceva® monotherapy using the Morisky scale;
- To describe the change in quality of life for patients treated with Tarceva® monotherapy, using the FACT-L questionnaire.

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