Study identifier:D822EC00001
ClinicalTrials.gov identifier:NCT05665374
EudraCT identifier:N/A
CTIS identifier:N/A
General Use-Results Study of Calquence capsules 100 mg in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
N/A
No
-
All
67
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use
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).
Arms | Assigned Interventions |
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