N/A
Completed N=171
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Non-Interventional Study
Source: ClinicalTrials.gov NCT02956967 ↗
Enrolled (actual)
171
Serious AEs
9.4%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With Any Significant Comorbidities — 42.7 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Significant Comorbidities |
42.7 | — |
| PRIMARY Percentage of Participants With Different Types of Haematological Malignancies |
0.6; 1.2; 1.8; 1.2 | — |
| PRIMARY Percentage of Participants With Different Types of Solid Tumour |
3.5; 1.2; 3.5; 1.2; 66.7; 1.2 | — |
| PRIMARY Duration of Solid Tumour in Participants Prior to Enrolment in Study |
1.0 | — |
| PRIMARY Number of Participants Who Received Chemotherapy Prior to Enrolment in Study |
51 | — |
| PRIMARY Duration of Different Types of Chemotherapies Received by Participants During Study |
— | — |
| PRIMARY Percentage of Participants With Response to Study Treatment |
— | — |
| SECONDARY Participants' Overall Satisfaction Scores in Response to the Study Treatment |
1.9 | — |
| SECONDARY Participant's Assessment for Nivestim Packaging |
144; 4; 21 | — |
| SECONDARY Participant's Assessment of Injection Site Pain and Tolerability |
53; 128; 42; 4; 0; 107 | — |
| SECONDARY Participant's Assessment of Overall Tolerability of Subcutaneous Injection |
75; 117; 20; 14; 3 | — |
| SECONDARY Percentage of Participants With Neutropenia |
0.0 | — |
| SECONDARY Percentage of Participants With at Least One Infection and Serious Infection |
8.2; 1.8 | — |
| SECONDARY Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 |
3.36; -0.03; 1.76; 1.35; 3.49; 4.50 | — |
| SECONDARY Minimum Value of Absolute Neutrophil Count |
2.49; 3.12; 2.95; 4.90; 9.20; 4.15 | — |
| SECONDARY Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle |
8.22; 6.50; 6.52; 1.78; 0.70; 46.15 | — |
| SECONDARY Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count |
6.18; 3.26; 3.70; -3.13; -8.50; 42.00 | — |
| SECONDARY Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count |
5.0; 4.0; 4.0; 6.0; 9.0; 5.5 | — |
| SECONDARY Percentage of Participants With Febrile Neutropenia |
0.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02956967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.