Descriptive Study of the Incidence of Malignancy in Patients with Severe Asthma Overall and Among Those Receiving Benralizumab and Other Therapies, a Post Authorization Safety Study

First published 14/11/2018

Last updated 07/05/2025

EU PAS number:

EUPAS26310

Study

Finalised

Documents

Study protocol

Initial protocol

D3250R00042-pass-csp-v4_Redacted

English (391.09 KB - PDF)View document

Updated protocol

D3250R00042 - Protocol v.5_Redacted

First published: 22/02/2024

English (373.74 KB - PDF)View document

Study results

Study report

D3250R00042 - Protocol v.2_Redacted

English (629 KB - PDF)View document

D3250R00042 - Protocol v.3_Redacted

English (3.23 MB - PDF)View document

D3250R00042 EUPAS26310-PASS-Interim study report_Redacted

English (844.24 KB - PDF)View document

D3250R00042- Second Interim Study Report_Redacted

English (7.37 MB - PDF)View document

D3250R00042-protocol-v1_Redacted

English (527.12 KB - PDF)View document

EUPAS26310_Malignancy PASS_ Third Interim Report_Redacted.pdf

English (981.69 KB - PDF)View document

Malignancy PASS Final CSR Synopsis (EUPAS26310_NCT04991805).pdf

English (202.06 KB - PDF)View document

Other information

Study, other information

D3250R00042 - Protocol v.2_Redacted.pdf

English (629 KB - PDF)View document

D3250R00042 - Protocol v.3_Redacted.pdf

English (3.23 MB - PDF)View document

D3250R00042 EUPAS26310-PASS-Interim study report_Redacted.pdf

English (844.24 KB - PDF)View document

D3250R00042-protocol-v1_Redacted.pdf

English (527.12 KB - PDF)View document

ENCePP Seal

ENCePP Seal documents

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