Study identifier:D8224C00001
ClinicalTrials.gov identifier:NCT04872621
EudraCT identifier:N/A
CTIS identifier:N/A
Calquence 100 mg capsules General Drug Use-Results Study; All Patient Investigation in patients with relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma)
relapsed or refractory Chronic Lymphocytic Leukemia (including Small Lymphocytic Lymphoma)
N/A
No
-
All
104
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting. This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.
Location
Location
Hokkaido, Japan, D8224C00001
Location
Aomori, Japan, D8224C00001
Location
Miyagi, Japan, D8224C00001
Location
Chiba, Japan, D8224C00001
Location
Tokyo, Japan, D8224C00001
Location
Tokyo, Japan, D8224C00001
Location
Kanagawa, Japan, D8224C00001
Location
Aichi, Japan, D8224C00001
Arms | Assigned Interventions |
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