Home Administration Of Nivestim(tm) In The Primary Prophylaxis Of Chemotherapy- Induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home Short Name: Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 171
- 试验地点
- 28
- 主要终点
- Percentage of Participants With Different Types of Haematological Malignancies
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of Participants With Different Types of Haematological Malignancies
时间窗: Baseline (Day 1)
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.
Percentage of Participants With Any Significant Comorbidities
时间窗: Baseline (Day 1)
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.
Percentage of Participants With Different Types of Solid Tumour
时间窗: Baseline (Day 1)
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.
Duration of Solid Tumour in Participants Prior to Enrolment in Study
时间窗: Baseline (Day 1)
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.
Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
时间窗: Baseline (Day 1)
Percentage of Participants With Response to Study Treatment
时间窗: Baseline up to 6 months
Duration of Different Types of Chemotherapies Received by Participants During Study
时间窗: Baseline up to 6 months
次要结局
- Percentage of Participants With Febrile Neutropenia(Baseline up to 6 months)
- Participants' Overall Satisfaction Scores in Response to the Study Treatment(Baseline up to 6 months)
- Participant's Assessment of Overall Tolerability of Subcutaneous Injection(Baseline up to 6 months)
- Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count(Cycle 1, 2, 3, 4, 5, 6)
- Percentage of Participants With at Least One Infection and Serious Infection(Baseline up to 6 months)
- Minimum Value of Absolute Neutrophil Count(Cycle 1, 2, 3, 4, 5, 6)
- Participant's Assessment for Nivestim Packaging(Baseline up to 6 months)
- Percentage of Participants With Neutropenia(Baseline up to 6 months)
- Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6(Baseline, Cycle 1, 2, 3, 4, 5, 6)
- Participant's Assessment of Injection Site Pain and Tolerability(Baseline up to 6 months)
- Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle(End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6))
- Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count(Cycle 1, 2, 3, 4, 5, 6)