Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

Pfizer

Status: Completed

Conditions: Non-Interventional Study

Treatments: Other: Overall satisfaction questionnaires of home use of Nivestim

Study type: Observational

Funder types: Industry

Identifiers

NCT02956967

C1121004 (Other Identifier)

ZOB-NIV-1504

Details and patient eligibility

About

Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients ≥ 18 years
• Declaration of informed consent signed by patient
• Patients with a solid tumour or with a malignant haematological tumour
• Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
• GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
• Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN

Exclusion criteria

• Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
• Patients who are hypersensitive to one of the excipients of NivestimTM
• Patients not undergoing chemotherapy
• Patients being treated curatively or as secondary prophylaxis with G-CSF

Trial design

171 participants in 1 patient group

Patients receiving Nivestim

Treatment:

Other: Overall satisfaction questionnaires of home use of Nivestim