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

Pfizer171 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

171

Conditions

Non-Interventional Study

Interventions

Overall satisfaction questionnaires of home use of NivestimOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Office of Manfred Welslau

Aschaffenburg, Germany

Outcomes

Primary Outcomes

Percentage of Participants With Any Significant Comorbidities

Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.

Time frame: Baseline (Day 1)

Percentage of Participants With Different Types of Haematological Malignancies

Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.

Time frame: Baseline (Day 1)

Percentage of Participants With Different Types of Solid Tumour

Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.

Time frame: Baseline (Day 1)

Duration of Solid Tumour in Participants Prior to Enrolment in Study

Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.

Time frame: Baseline (Day 1)

Number of Participants Who Received Chemotherapy Prior to Enrolment in Study

Time frame: Baseline (Day 1)

Duration of Different Types of Chemotherapies Received by Participants During Study

Data from ClinicalTrials.gov

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Secondary Outcomes

Participants' Overall Satisfaction Scores in Response to the Study Treatment

Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.

Time frame: Baseline up to 6 months

Participant's Assessment for Nivestim Packaging

Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.

Time frame: Baseline up to 6 months

Participant's Assessment of Injection Site Pain and Tolerability

Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.

Time frame: Baseline up to 6 months

Participant's Assessment of Overall Tolerability of Subcutaneous Injection

Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.

Time frame: Baseline up to 6 months

Percentage of Participants With Neutropenia

Percentage of participants with absolute neutrophil count (greater than)\>0.5\*10\^9 Neutrophils per Liter were reported in this outcome measure.

Time frame: Baseline up to 6 months

Percentage of Participants With at Least One Infection and Serious Infection

Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Baseline up to 6 months

Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6

Time frame: Baseline, Cycle 1, 2, 3, 4, 5, 6

Minimum Value of Absolute Neutrophil Count

Time frame: Cycle 1, 2, 3, 4, 5, 6

Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle

Time frame: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)

Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count

Time frame: Cycle 1, 2, 3, 4, 5, 6

Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count

Time frame: Cycle 1, 2, 3, 4, 5, 6

Percentage of Participants With Febrile Neutropenia

Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (\>=) 38.0 degree Celsius and absolute neutrophil count of less than (\<) 1.0 × 10\^9 Neutrophils per Liter.

Time frame: Baseline up to 6 months