Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ADRs | the incidence of ADRs related to Calquence Safety specifications: Haemorrhage, infection, bone narrow depression, arrhythmia, ischemic heart disease, tumour lysis syndrome, interstitial lung disease, and second primary malignancy | 52weeks |
Not provided
Not provided
Inclusion Criteria:
Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -
Exclusion Criteria:
None
-
Not provided
Not provided
Not provided
Not provided
Patients with relapsed or refractory chronic lymphocytic leukaemia (small lymphocytic lymphoma) who are treated with the product
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | AstraZeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | D8224C00001 | Japan | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
Not provided
Not provided
Not provided
| Aichi |
| Japan |
| Research Site | Akita | Japan |
| Research Site | Aomori | D8224C00001 | Japan |
| Research Site | Chiba | D8224C00001 | Japan |
| Research Site | Chiba | Japan |
| Research Site | Fukui | Japan |
| Research Site | Fukuoka | D8224C00001 | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Gifu | Japan |
| Research Site | Gunma | D8224C00001 | Japan |
| Research Site | Gunma | Japan |
| Research Site | Hiroshima | D8224C00001 | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Hokkaido | D8224C00001 | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | D8224C00001 | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | D8224C00001 | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Ishikawa | Japan |
| Research Site | Kagoshima | D8224C00001 | Japan |
| Research Site | Kagoshima | Japan |
| Research Site | Kanagawa | D8224C00001 | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kochi | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | D8224C00001 | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | D8224C00001 | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Miyazaki | Japan |
| Research Site | Nagano | Japan |
| Research Site | Nagasaki | D8224C00001 | Japan |
| Research Site | Nagasaki | Japan |
| Research Site | Nara | Japan |
| Research Site | Niigata | Japan |
| Research Site | Numakunai | Japan |
| Research Site | Okayama | Japan |
| Research Site | Okinawa | Japan |
| Research Site | Osaka | D8224C00001 | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saitama | D8224C00001 | Japan |
| Research Site | Saitama | Japan |
| Research Site | Shiga | D8224C00001 | Japan |
| Research Site | Shiga | Japan |
| Research Site | Shimane | Japan |
| Research Site | Shizuoka | D8224C00001 | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tokyo | D8224C00001 | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Toyama | Japan |
| Research Site | Wakayama | D8224C00001 | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yamagata | Japan |
| Research Site | Yamaguchi | Japan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided