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Traduction de «data from two early clinical » (Néerlandais → Français) :

Data from two early clinical studies presented at the CTRC-San Antonio Breast Cancer Symposium showed the potential of Afinitor to reverse resistance to Herceptin ® in women with metastatic breast cancer.

Des données provenant de deux études cliniques au stade initial présentées lors du CTRC-San Antonio Breast Cancer Symposium ont montré la capacité potentielle d’Afinitor de contrer la résistance à Herceptin ® chez des patientes atteintes d'un cancer du sein métastasé.


Table 2: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical ...[+++]

Table 4: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical ...[+++]


The first submissions were previously planned for 2009, but were accelerated to December 2008 after data from two clinical studies showed adults and children achieved rapid and long-lasting clinical remission of symptoms of these diseases.

Prévues initialement en 2009, les premières demandes d’autorisation ont été avancées à décembre 2008, après que des résultats de deux études cliniques ont montré que les adultes et les enfants obtenaient rapidement des rémissions cliniques de longue durée des symptômes de ces maladies.


The Resident Assessment Instrument (RAI) 444 is originally developed to Only for breast cancer and colon cancer, the US has higher survival rates assess the care needs of the elderly in institutions, and has later been than Belgium (data shown in documentation sheet in Supplement S1). To extended with instruments for different care settings and subgroups. In be able to distinguish the effect of early screening from the actual care, Belgium a national pilot project (the BelRAI) is ongoing, but is not yet implemente ...[+++]

Belgium a national pilot project (the BelRAI) is ongoing, but is not yet be able to distinguish the effect of early screening from the actual care, implemented in all care settings: the assessment instruments for home care, relative survival rates should be compared across countries by stage, for long-term care facilities and acute care have already been adapted to information which is not yet available at international level. the Belgian situation (details in Appendix C).


Clinical trials are underway in other age groups, including as young as from two months, to protect against the serogroups A, C, W-135 and Y found with this often-fatal bacterial infection.

Des essais cliniques sont en cours dans d’autres tranches d’âges, dès l’âge de deux mois, pour les protéger contre les sérogroupes A, C, W-135 et Y que l’on trouve dans cette maladie bactérienne souvent mortelle.


- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September

2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA


In 2003, we established a Novartis online registry providing retrospective data from more than 250 global and local clinical studies.

En 2003, nous avons ouvert sur Internet un site sur lequel sont archivés les résultats de plus de 250 essais cliniques conduits à petite ou à large échelle.


Recently launched products provided important contributions in Oncology (USD 2.5 billion, +14% lc), which benefited from the new anti-cancer medicine Afinitor (USD 32 million) approved in 2009 and new clinical data supporting Tasigna (USD 68 million, +101% lc).

Oncologie (USD 2,5 milliards, +14% en m. l) a profité d’importantes contributions des nouveaux produits, en particulier Afinitor (USD 32 millions), médicament anticancer homologué en 2009, et de nouveaux résultats cliniques supportant Tasigna (USD 68 millions, +101% en m. l.).


In the US, all clinical studies to support resubmission have been started following a Complete Response letter from the FDA in October 2009 requesting additional data.

Aux Etats-Unis, toutes les études cliniques destinées à soutenir le dépôt d’une nouvelle demande ont débuté après réception en octobre 2010 d’une « complete response letter » de la FDA demandant des données supplémentaires.




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Date index: 2023-08-05
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