Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study : General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "CALQUENCE") used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act)..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 09. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: December 27, 2022, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
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| Study ID: |
NCT05665374 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG008850623 |
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| 245 | 1 | 0 | |a Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study |b General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma) |
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| 520 | |a To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "CALQUENCE") used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act). | ||
| 650 | 2 | |a Lymphoma | |
| 650 | 2 | |a Leukemia | |
| 650 | 2 | |a Leukemia, Lymphoid | |
| 650 | 2 | |a Leukemia, Lymphocytic, Chronic, B-Cell | |
| 650 | 4 | |a Study Type: Observational | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
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