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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data
from AstraZeneca group of companies sponsored clinical trials via the request portal
Vivli.org. All requests will be evaluated as 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 approved

CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb

CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb

This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton’s tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)

MEOI and HRQoL in CLL patients treated with BTKis

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Medical Events of Interest and Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients Initiating Treatment with Bruton’s Tyrosine Kinase Inhibitors Acalabrutinib or Ibrutinib

To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.

To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period

To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period.

To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period

Arms	Assigned Interventions
Acalabrutinib CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb	-
Ibrutinib CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb	-

MEOI and HRQoL in CLL patients treated with BTKis

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