Clinical Trial: Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Home Administration Of Nivestimtm In The Primary Prophylaxis Of Chemotherapy-induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home
Brief Summary: 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
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome:
- Mean age of patients enrolled [ Time Frame: Baseline ]
- Percentage of patients enrolled with any previous or ongoing significant comorbidities [ Time Frame: Baseline ]
- Percentage and type of haematological malignancy diagnosed [ Time Frame: Baseline ]
- Percentage and type of solid tumor diagnosed [ Time Frame: Baseline ]
- Mean time since diagnosis of solid tumour or malignant haematological tumour prior to enrollment [ Time Frame: Baseline ]
- percentage of males and females enrolled [ Time Frame: Baseline ]
- Mean weight of patients enrolled [ Time Frame: Baseline ]
- Mean body mass index (BMI) of patients enrolled [ Time Frame: Baseline ]
- Number of patients receiving chemotherapy prior to enrollment [ Time Frame: Baseline ]
- Mean duration and type of chemotherapy received during study [ Time Frame: Baseline up to approximately 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of patients who have a positive satisfaction with Nivestim [ Time Frame: Baseline up to approximately 6 months ]
- Patients' overall rating of satisfaction with Nivestim [ Time Frame: Baseline up to approximately 6 months ]
- Patient assessment of Nivestim packaging [ Time Frame: Baseline up to approximately 6 months ]Evaluation of Nivestim™ packaging Nivestim™ handling instructions Manageability of Nivestim™ syringes
- Patient assessment of tolerability of Nivestim at the injection site [ Time Frame: Baseline up to 6 months ]Patients' rating of Tolerability of Nivestim™ at the injection site Painfulness of the needle insertion into the skin Overall tolerability of the subcutaneous injection of Nivestim™
- Percentage of patients who experience neutropenia [ Time Frame: Baseline up to approximately 6 months ]
- Percentage of patients who experience an infection [ Time Frame: Baseline up to approximately 6 months ]
- Change from baseline in absolute neutrophil count [ Time Frame: Baseline up to approximately 6 months ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: November 3, 2016
Date Started: September 23, 2015
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017