Non-Interventional Study
Conditions
Keywords
Non-Interventional Study
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
Interventions
OTHEROverall satisfaction questionnaires of home use of Nivestim
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response to Study Treatment | Baseline up to 6 months | — |
| Percentage of Participants With Any Significant Comorbidities | 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 Haematological Malignancies | 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 Different Types of Solid Tumour | 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 | 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 | Baseline (Day 1) | — |
| Duration of Different Types of Chemotherapies Received by Participants During Study | Baseline up to 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Baseline, Cycle 1, 2, 3, 4, 5, 6 | — |
| Minimum Value of Absolute Neutrophil Count | Cycle 1, 2, 3, 4, 5, 6 | — |
| 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 | — |
| Percentage of Participants With Febrile Neutropenia | Baseline up to 6 months | 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. |
| Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 1, 2, 3, 4, 5, 6 | — |
| Participants' Overall Satisfaction Scores in Response to the Study Treatment | Baseline up to 6 months | 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. |
| Participant's Assessment for Nivestim Packaging | Baseline up to 6 months | 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. |
| Participant's Assessment of Injection Site Pain and Tolerability | Baseline up to 6 months | 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. |
| Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Baseline up to 6 months | 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. |
| Percentage of Participants With Neutropenia | Baseline up to 6 months | Percentage of participants with absolute neutrophil count (greater than)\>0.5\*10\^9 Neutrophils per Liter were reported in this outcome measure. |
| Percentage of Participants With at Least One Infection and Serious Infection | Baseline up to 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 6 months | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE 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 or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nivestim Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days. | 171 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Missing | 1 |
| Overall Study | Reason non-related to neutropenia | 10 |
| Overall Study | Termination of Nivestim administration | 29 |
Baseline characteristics
| Characteristic | Nivestim |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 11.36 |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 171 |
| other Total, other adverse events | 74 / 171 |
| serious Total, serious adverse events | 16 / 171 |
Outcome results
Primary
Duration of Different Types of Chemotherapies Received by Participants During Study
Time frame: Baseline up to 6 months
Population: The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Primary
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)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nivestim | Duration of Solid Tumour in Participants Prior to Enrolment in Study | 1.0 years | Standard Deviation 2.86 |
Primary
Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
Time frame: Baseline (Day 1)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivestim | Number of Participants Who Received Chemotherapy Prior to Enrolment in Study | 51 participants |
Primary
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)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivestim | Percentage of Participants With Any Significant Comorbidities | 42.7 percentage of participants |
Primary
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)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Percentage of Participants With Different Types of Haematological Malignancies | Non-Hodgkin's lymphoma | 1.8 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Haematological Malignancies | Hodgkin's lymphoma | 0.6 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Haematological Malignancies | Leukemia | 1.2 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Haematological Malignancies | Other stem cell transformations | 1.2 percentage of participants |
Primary
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)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Digestive organ: Stomach Tumour | 1.2 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Digestive organ: Colon/Rectum Tumour | 3.5 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Digestive organ: Oesophageal Tumour | 1.2 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Digestive organ: Pancreatic Tumour | 3.5 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Gynaecological: Breast Tumour | 66.7 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Gynaecological: Endometrial Tumour | 1.2 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Gynaecological: Ovarian Tumour | 4.1 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Lungs: Non-small cell lung cancer | 3.5 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Lungs: Small cell lung cancer | 1.8 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Urological: Bladder Tumour | 0.6 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Urological: Prostate Gland Tumour | 2.9 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Urological: Testicles Tumour | 0.6 percentage of participants |
| Nivestim | Percentage of Participants With Different Types of Solid Tumour | Other organ Tumour | 4.1 percentage of participants |
Primary
Percentage of Participants With Response to Study Treatment
Time frame: Baseline up to 6 months
Population: The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Secondary
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)
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 1 | 8.22 10^9 Neutrophils per Liter | Standard Deviation 9.874 |
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 2 | 6.50 10^9 Neutrophils per Liter | Standard Deviation 6.297 |
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 3 | 6.52 10^9 Neutrophils per Liter | Standard Deviation 7.57 |
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 4 | 1.78 10^9 Neutrophils per Liter | Standard Deviation 0.873 |
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 5 | 0.70 10^9 Neutrophils per Liter | — |
| Nivestim | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | Cycle 6 | 46.15 10^9 Neutrophils per Liter | Standard Deviation 51.831 |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, number analyzed (n) signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Baseline | 3.36 10^9 Neutrophils per Liter | Standard Deviation 3.005 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 1 | -0.03 10^9 Neutrophils per Liter | Standard Deviation 0.528 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 2 | 1.76 10^9 Neutrophils per Liter | Standard Deviation 5.304 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 3 | 1.35 10^9 Neutrophils per Liter | Standard Deviation 4.787 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 4 | 3.49 10^9 Neutrophils per Liter | Standard Deviation 1.924 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 5 | 4.50 10^9 Neutrophils per Liter | Standard Deviation 4.107 |
| Nivestim | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Change at Cycle 6 | 1.00 10^9 Neutrophils per Liter | Standard Deviation 1.556 |
Secondary
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Time frame: Cycle 1, 2, 3, 4, 5, 6
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 1 | 6.18 10^9 Neutrophils per Liter | Standard Deviation 9.548 |
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 2 | 3.26 10^9 Neutrophils per Liter | Standard Deviation 5.872 |
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 3 | 3.70 10^9 Neutrophils per Liter | Standard Deviation 7.45 |
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 4 | -3.13 10^9 Neutrophils per Liter | Standard Deviation 2.653 |
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 5 | -8.50 10^9 Neutrophils per Liter | — |
| Nivestim | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 6 | 42.00 10^9 Neutrophils per Liter | Standard Deviation 52.184 |
Secondary
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Time frame: Cycle 1, 2, 3, 4, 5, 6
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 1 | 5.0 days |
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 2 | 4.0 days |
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 3 | 4.0 days |
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 4 | 6.0 days |
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 5 | 9.0 days |
| Nivestim | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 6 | 5.5 days |
Secondary
Minimum Value of Absolute Neutrophil Count
Time frame: Cycle 1, 2, 3, 4, 5, 6
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 1 | 2.49 10^9 Neutrophils per Liter | Standard Deviation 3.271 |
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 2 | 3.12 10^9 Neutrophils per Liter | Standard Deviation 3.485 |
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 3 | 2.95 10^9 Neutrophils per Liter | Standard Deviation 3.015 |
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 4 | 4.90 10^9 Neutrophils per Liter | Standard Deviation 1.941 |
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 5 | 9.20 10^9 Neutrophils per Liter | — |
| Nivestim | Minimum Value of Absolute Neutrophil Count | Cycle 6 | 4.15 10^9 Neutrophils per Liter | Standard Deviation 0.354 |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Participant's Assessment for Nivestim Packaging | Easy | 144 participants |
| Nivestim | Participant's Assessment for Nivestim Packaging | Complicated | 4 participants |
| Nivestim | Participant's Assessment for Nivestim Packaging | Missing | 21 participants |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Injection Site Pain: Did not feel anything | 53 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Injection Site Pain: Did not feel much | 128 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Injection Site Pain: Light stitch | 42 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Injection Site Pain: Painful | 4 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Injection Site Pain: Very painful | 0 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Tolerability: Very good | 107 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Tolerability: Good | 106 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Tolerability: Satisfactory | 12 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Tolerability: Did not tolerate well | 4 participants |
| Nivestim | Participant's Assessment of Injection Site Pain and Tolerability | Tolerability: Did not tolerate at all | 0 participants |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Did not tolerate well | 14 participants |
| Nivestim | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Good | 117 participants |
| Nivestim | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Very good | 75 participants |
| Nivestim | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Satisfactory | 20 participants |
| Nivestim | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | Did not tolerate at all | 3 participants |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nivestim | Participants' Overall Satisfaction Scores in Response to the Study Treatment | 1.9 units on a scale | Standard Deviation 0.85 |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivestim | Percentage of Participants With at Least One Infection and Serious Infection | Infection | 8.2 percentage of participants |
| Nivestim | Percentage of Participants With at Least One Infection and Serious Infection | Serious Infection | 1.8 percentage of participants |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivestim | Percentage of Participants With Febrile Neutropenia | 0.6 percentage of participants |
Secondary
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
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivestim | Percentage of Participants With Neutropenia | 0.0 percentage of participants |
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE 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 or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Time frame: Baseline up to 6 months
Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivestim | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 81 Participants |
| Nivestim | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 16 Participants |