Use of Erythropoiesis Stimulating Agents (ESA) in Patients With Non-myeloid Malignancies Receiving Myelosuppressive Chemotherapy 2014 – 2021 (20170210)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28521
• EU PAS number:
  EUPAS24079
• Study ID:
  28521
• Official title and acronym:
  Use of Erythropoiesis Stimulating Agents (ESA) in Patients With Non-myeloid Malignancies Receiving Myelosuppressive Chemotherapy 2014 – 2021 (20170210)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study utilizes data from the Truven MarketScan claims database and the US-based Oncology Services Comprehensive Electronic Records (OSCER) database. Both databases were used to evaluate the use of ESAs after the initiation of myelosuppressive chemotherapy among patients diagnosed with non-myeloid malignancy. Patients were further categorized into the following specific tumor types: breast cancer, breast cancer receiving adjuvant therapy, metastatic breast cancer, CRC, lymphoma, lung cancer, and NSCLC. The study aims are: 1) To estimate the proportion of patients with non myeloid malignancies receiving an ESA over a 180-day follow-up period after initiation of myelosuppressive chemotherapy by calendar year, overall and stratified by specific tumor types (described above); and 2) To describe the hemoglobin (Hb) levels and estimate the proportion of patients with Hb values greater than 10 g/dL immediately preceding ESA treatment initiation in patients with non-myeloid malignancies after initiation of myelosuppressive chemotherapy by calendar year, overall and stratified by specific tumor types described above.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 02/01/2017

Actual: 02/01/2017

Study start date

Planned: 19/05/2017

Actual: 19/05/2017

Data analysis start date

Planned: 01/09/2023

Actual: 22/09/2023

Date of interim report, if expected

Planned: 31/03/2018

Date of final study report

Planned: 31/01/2024

Actual: 31/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 English.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable