Study identifier:D3250R00042
ClinicalTrials.gov identifier:NCT04991805
EudraCT identifier:N/A
CTIS identifier:N/A
Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study
asthma, Neoplasms
N/A
No
-
All
14000
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.
Location
Location
Norwich, Norfolk, United Kingdom, NR11 6UN
Location
Stockholm, Stockholm, Sweden, 128 61
Arms | Assigned Interventions |
---|---|
Benralizumab Patients who have received Benralizumab. | - |
Other biologics Patients who have received non benralizumab biologics. | - |
Non-biologic Patients who have received non biologic drug. | - |
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