Latest database descriptions

A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-t...

August 23 2022

Primary objective: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years.

Secondary objectives:
The secondary objectives of this study were to describe:
- The progression-free survival, time to progression and patients overall survival;
- Modalities of use of trastuzumab, the duration of treatment and the reasons leading to treatment discontinuation;
- Antineoplastic treatments in combination with trastuzumab and after discontinuation of trastuzumab treatment;
- Relevant biological tumor markers;
- The safety of trastuzumab treatment.

Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A

August 23 2022

Primary objective: To describe in CKD patients on dialysis the impact of comorbidities* on hemoglobin stability** after 6 months of treatment with Mircera® in routine clinical practice
* Patients’ comorbidities will be analyzed on the basis of the CCI.
** Hemoglobin stability is defined as a variation of +/- 1g/dL of hemoglobin level between the first Mircera® injection and the 6th month of treatment, without red blood cells transfusion during this period.

Secondary objectives:
- In the overall study population and in each subgroup of patients defined by a range of the Charlson comorbidity index (<=3, [4-5], [6-7], >=8):
- - To describe baseline characteristics of the patients;
- - To describe the monthly changes in hemoglobin level;
- - To describe monthly Mircera® dose.
- To describe patients’ vital status and all adverse events over the observation period with Mircera®;
- To describe the hemoglobin stability after 6 months of treatment with Mircera®, according to subgroups of Liu comorbidity index (<=3; [4-6]; [7-9]; >=10);
- To describe the proportion of patients with an Hb level within the range 10-12 g/dL with or without hemoglobin stability after 6 months of treatment with Mircera®, according to the subgroups of Charlson and Liu comorbidity indexes.

Pharmaco-epidemiological observational study of the clinical beneft of Neorecormon® in cancer patients with anaemia, according to early response to...

August 23 2022

Primary objective: To describe in real-life conditions the clinical benefit (i.e. transfusion sparing, maintenance of general health status, and professional and social activities) of NeoRecormon® in anaemic cancer patients, according to early response to treatment.
- Early response to NeoRecormon® was defined as an increase of hemoglobin concentration of at least 1 g/dL, 4 to 6 weeks after treatment initiation.

Secondary objectives:
In the total population and in each sub-population of patients [type of pathology (solid tumor, hematological malignancy or autograft), cancer pathology]:
1. to describe patients’ characteristics at inclusion;
2. to describe the use of NeoRecormon® and the compliance to current guidelines [Market Authorization (MA), EORTC];
3. to describe the evolution of hemoglobin (Hb) level;
4. to describe the evolution of iron status and vitamin supplementation;
5. to describe Adverse Events (AEs) and serious AEs (targeted and non-targeted AEs).

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.

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