Paul-Ehrlich-Institut

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Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 418

Studiencode: ML39704

Allgemeine Angaben

Institution: Roche Pharma AG, Grenzach-Wyhlen Auftraggeber: Roche Pharma AG, Grenzach-Wyhlen
Titel der NIS: NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS OF ATEZOLIZUMAB UNDER REAL-WORLD CONDITIONS IN PATIENTS WITH INOPERABLE LOCALLY-ADVANCED OR METASTATIC UROTHELIAL CARCINOMA OF THE URINARY TRACT (ANNOUNCE)
Ziel der NIS:

This study is a primary data collection non-interventional study designed to assess real-world effectiveness and safety of atezolizumab in treatment-naive patients with inoperable locally-advanced or metastatic UC ineligible for cisplatin-based chemotherapy. The choice of treatments, including atezolizumab, was at the discretion of the treating physician per local guidelines. In eligible patients who were chosen by their treating physicians to receive atezolizumab and who consented to participate in this study, atezolizumab was administered at a dosage of 1200 mg IV every 3 weeks as described in the atezolizumab Summary of Product Characteristics (SmPC). Atezolizumab treatment was to be continued until physician-assessed loss of clinical benefit (defined as the deterioration of disease-related symptoms), unacceptable toxicity, physician or patient decision to withdraw from therapy, or death, whichever occurred first. During the treatment period, patient data were to be collected approximately every 3 weeks at the clinic visits when atezolizumab was administered. Due to the premature termination the study duration was derived as: date of last patient data recorded in the study data base minus date of first patient data recorded in the study data base.

Ort der Durchführung: nur Deutschland NIS angefordert: nein
Patientenanzahl insgesamt: 22 Anzahl Ärzte insgesamt: 10
Patientenanzahl in Deutschland: 22 Ärzte in Deutschland: 10

Weitere Angaben und Unterlagen

Anzeige am: 20.12.2017 Geplanter Beginn: 28.12.2017 Geplantes Ende: 31.10.2018
Angezeigtes Ende der NIS am: 05.11.2019

Angaben zu den beobachteten Arzneimitteln, soweit angezeigt

Arzneimittelbezeichnung INN Zulassungs-Nr. ATC-Code Substanzklasse
Tecentriq 1.200 mg Konzentrat zur Herstellung einer Infusionslösung Atezolizumab EU/1/17/1220/001 L01XC32 Antineoplastische Arzneimittel, monoklonale Antikörper

Verfügbare Dokumente

Art des Dokuments
Beobachtungsplan, NIS 418 pdf
3MB
Abschlussbericht, NIS 418 pdf
1MB