Chemotherapy-induced Febrile Neutropenia
Conditions
Keywords
NHL, Breast Cancer, Lung Cancer
Brief summary
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Detailed description
Although a formal hypothesis will not be tested in this observational study, it is hypothesized that the clinical risk factors ranked as the most important when conducting FN risk assessments by investigators are aligned with international guidelines and published data. Also, that the investigator's decision to treat with G-CSF PP is influenced by clinical and non-clinical risk factors (such as distance from site, estimated subject compliance, and access to fully reimbursed G-CSF). Study Design: Prior to identifying eligible subjects, Investigators will be registered and will record baseline information. During this Baseline Investigator Assessment investigators will be provided with two lists of risk factors. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not (this list will also contain non clinical factors). They will also record their own FN risk intervention threshold, which is the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. Investigators will then prospectively and sequentially identify eligible subjects with NHL, breast or lung cancer who are due to initiate one of the permitted standard dose chemotherapy regimens listed in the protocol. The permitted chemotherapy regimens have an estimated intermediate FN risk (10%-20%) documented in published data and/or international guidelines. For each enrolled subject, Investigators will complete a Subject Assessment prior to the start of their chemotherapy. They will be provided with the same two lists of risk factors as in the Baseline Assessment and asked to complete them based on each specific subject. Investigators must rank selected risk factors that they consider to be the most important when assessing 1) overall FN risk (only scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment will be used or not. They will also document their final estimated FN risk score as a percentage based on the subject's medical history and standard of care (SOC) assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP will be administered. Investigators will record which type of G-CSF they plan to use if one will be used. End of Study for a subject will occur once these activities have been completed, and a prescription for the first cycle of chemotherapy has been written. The subject data collected will only be historical subject information and laboratory data from SOC assessments performed prior to beginning chemotherapy treatment. No data will be collected after the initiation of chemotherapy. The approach to the statistical analysis will be generally descriptive in nature. The primary analysis will be conducted at two levels; investigator level and the subject level. It is expected that the opinions of investigators at a single site (that is, a department within a cancer treatment centre) will be correlated. Also, that the opinions about subjects from a single investigator will be more alike than subjects of other investigators; adjustments will be made in the analyses to account for this. Confidence intervals for the investigator level analysis and the subject level data will obtained from Multi-level Modelling (MLM) to allow for the expected intra-site and intra-investigator correlation of investigators within sites and subjects within investigator. In general, categorical data will be summarised by the number and percentage of subjects in each category. Continuous data will be summarised by mean, standard deviation, median, lower and upper quartiles, minimum and maximum values. Two-sided exact 95% confidence intervals (obtained using MLM) will be presented, where appropriate.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Any stage NHL, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or breast cancer initiating a new chemotherapy course * Scheduled to receive one of the permitted standard dose chemotherapy regimens with an estimated intermediate (10%-20%) FN risk according to published data or guidelines (planned dose modifications +/-10% are allowable). * Before any study-specific procedure, the appropriate written informed consent must be obtained where this is required by local regulations
Exclusion criteria
* Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency (EMA) or competent authority for any indication, * Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated) * Prior stem-cell transplantation (includes bone marrow transplantation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Baseline (prior to participant enrolment) | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Assessed at Baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group |
| Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | At enrolment, prior to chemotherapy initiation | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Assessed at baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Assessed at Baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. |
| Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Assessed at baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Assessed at Baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | At enrolment, prior to chemotherapy initiation. | Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP | At Baseline and at enrolment, prior to chemotherapy initiation. | At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1. |
| Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Assessed at Baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | At enrolment, prior to chemotherapy initiation. | For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. |
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Assessed at baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators. |
| Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Assessed at baseline, prior to participant enrolment. | During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group. |
Countries
Australia, Austria, Canada, France, Germany, Greece, Ireland, Italy, Poland, Romania, Spain
Participant flow
Recruitment details
The first patient was enrolled on 13 December 2012 and the last patient enrolled on 08 January 2014. There were 205 registered investigators, 35 of whom did not enrol any participants and 5 who did not enrol any eligible participants and were excluded from the primary analysis set - investigators (PASI).
Participants by arm
| Arm | Count |
|---|---|
| Primary Analysis Set | 944 |
| Total | 944 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligibility determined | 63 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Primary Analysis Set |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 11.4 |
| Investigator Specialty Gynecological Surgeon | 2 investigators |
| Investigator Specialty Hematologist | 31 investigators |
| Investigator Specialty Medical Gynecologist | 4 investigators |
| Investigator Specialty Medical Oncologist | 110 investigators |
| Investigator Specialty Pulmonologist | 10 investigators |
| Investigator Specialty Radiation Oncologist | 8 investigators |
| Number of years in oncology/hematology clinical practice ≤ 10 years | 48 investigators |
| Number of years in oncology/hematology clinical practice > 10 years | 117 investigators |
| Sex: Female, Male Female | 554 Participants |
| Sex: Female, Male Male | 390 Participants |
| Tumor Type Breast cancer | 395 participants |
| Tumor Type Non-Hodgkin's lymphoma (NHL) | 182 participants |
| Tumor Type Non-small cell lung cancer (NSCLC) | 248 participants |
| Tumor Type Small-cell lung cancer (SCLC) | 119 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Time frame: Baseline (prior to participant enrolment)
Population: Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Age | 73.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Chemotherapy agents in the backbone | 88.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Anthracyclines | 41.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Taxanes | 25.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Platinum(s) | 22.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Alkylating agents | 21.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Topoisomerase II inhibitors | 13.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Topoisomerase I inhibitors | 11.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Gemcitabine | 9.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Vinorelbine | 9.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Other agents | 2.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia | Age and chemotherapy agents in the backbone | 66.3 percentage of investigators |
Primary
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group
Time frame: Assessed at Baseline, prior to participant enrolment.
Population: Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Chemotherapy agents in the backbone | 88.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | History of prior FN | 83.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Baseline laboratory values | 76.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Age | 73.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Prior chemotherapy | 70.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Guidelines | 69.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Prior radiotherapy involving bone marrow | 64.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | ECOG/Karnofsky performance status | 64.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Tumor type | 62.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Comorbidities | 62.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Documented bone marrow involvement | 62.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Tumor stage | 61.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Treatment intent | 50.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Nutritional status | 49.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Medications taken | 47.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Current infection | 45.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Concurrent radiotherapy | 42.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Personal experience of chemotherapy regimen risk | 40.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Open wounds | 37.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Planned relative dose intensity | 25.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Female gender | 23.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Other disease/treatment related | 4.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) | Other patient related | 2.4 percentage of investigators |
Primary
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
Time frame: At enrolment, prior to chemotherapy initiation
Population: Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Age | 39.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Chemotherapy agents in the backbone | 92.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Anthracyclines | 36.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Taxanes | 17.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Platinum(s) | 9.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Alkylating agents | 6.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Topoisomerase II inhibitors | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Vinorelbine | 1.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Topoisomerase I inhibitors | 0.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Gemcitabine | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor | Other agents | NA percentage of participants |
Primary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Concurrent radiotherapy | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Open wounds | 2.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Other patient related | 2.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Other disease/treatment related | 0.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Chemotherapy agents in the backbone | 92.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Tumor type | 72.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Guidelines | 61.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Tumor stage | 42.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Age | 39.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Treatment intent | 30.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | ECOG/Karnofsky performance status | 27.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Female gender | 18.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Comorbidities | 15.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Baseline laboratory values | 15.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Personal experience of chemotherapy regimen risk | 15.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Prior chemotherapy | 14.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Nutritional status | 8.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Planned relative dose intensity | 7.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Medications taken | 5.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | History of prior FN | 4.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Documented bone marrow involvement | 4.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Prior radiotherapy involving bone marrow | 4.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important | Current infection | 3.7 percentage of participants |
Secondary
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.
Time frame: Assessed at Baseline, prior to participant enrolment.
Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Chemotherapy agents in the backbone | 88.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | History of prior FN | 82.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Guidelines | 74.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Baseline laboratory values | 71.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Age | 68.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Prior chemotherapy | 67.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | ECOG/Karnofsky performance status | 64.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Comorbidities | 64.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Tumor stage | 64.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Prior radiotherapy involving bone marrow | 63.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Documented bone marrow involvement | 57.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Tumor type | 56.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Treatment intent | 55.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Nutritional status | 53.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Medications taken | 49.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Current infection | 44.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Open wounds | 42.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Personal experience of chemotherapy regimen risk | 40.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Concurrent radiotherapy | 39.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Female gender | 32.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Planned relative dose intensity | 29.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Other disease/treatment related | 5.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty | Other patient related | 2.7 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: Assessed at Baseline, prior to participant enrolment.
Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Chemotherapy agents in the backbone | 91.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | History of prior FN | 87.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Guidelines | 73.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Baseline laboratory values | 83.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Age | 72.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Prior chemotherapy | 75.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | ECOG/Karnofsky performance status | 58.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Comorbidities | 68.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Tumor stage | 58.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Prior radiotherapy involving bone marrow | 76.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Documented bone marrow involvement | 78.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Tumor type | 65.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Treatment intent | 49.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Nutritional status | 46.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Medications taken | 51.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Current infection | 40.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Open wounds | 44.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Personal experience of chemotherapy regimen risk | 32.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Concurrent radiotherapy | 45.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Female gender | 19.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Planned relative dose intensity | 21.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Other disease/treatment related | 3.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Other patient related | 3.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Tumor type | 60.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Chemotherapy agents in the backbone | 87.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Personal experience of chemotherapy regimen risk | 39.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | History of prior FN | 78.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Treatment intent | 47.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Guidelines | 62.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Planned relative dose intensity | 23.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Baseline laboratory values | 79.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Nutritional status | 47.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Age | 77.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Concurrent radiotherapy | 34.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Prior chemotherapy | 72.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Medications taken | 50.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | ECOG/Karnofsky performance status | 74.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Other patient related | 2.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Comorbidities | 62.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Current infection | 55.6 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Tumor stage | 64.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Female gender | 10.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Prior radiotherapy involving bone marrow | 61.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Open wounds | 39.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Documented bone marrow involvement | 63.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type | Other disease/treatment related | 2.6 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: Assessed at Baseline, prior to participant enrolment.
Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Chemotherapy agents in the backbone | 89.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | History of prior FN | 89.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 73.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 71.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Age | 68.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Prior chemotherapy | 68.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 54.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Comorbidities | 52.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Tumor stage | 60.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Prior radiotherapy involving bone marrow | 65.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Documented bone marrow involvement | 58.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Tumor type | 60.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 47.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Nutritional status | 46.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 45.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Current infection | 39.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Open wounds | 30.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Personal experience of chemotherapy regimen risk | 33.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Concurrent radiotherapy | 44.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Female gender | 22.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 27.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Other disease/treatment related | 4.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Other patient related | 2.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Tumor type | 63.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Chemotherapy agents in the backbone | 87.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Personal experience of chemotherapy regimen risk | 43.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | History of prior FN | 79.6 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 52.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 67.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 25.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 76.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Nutritional status | 49.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Age | 74.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Concurrent radiotherapy | 41.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Prior chemotherapy | 71.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 48.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 68.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Other patient related | 2.6 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Comorbidities | 67.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Current infection | 47.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Tumor stage | 61.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Female gender | 24.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Prior radiotherapy involving bone marrow | 63.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Open wounds | 40.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Documented bone marrow involvement | 62.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology | Other disease/treatment related | 3.8 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.
Time frame: Assessed at baseline, prior to participant enrolment.
Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Outcome of the overall FN risk assessment | 88.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Treatment intent | 78.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Age | 77.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Guidelines | 75.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Baseline laboratory values | 73.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | ECOG/Karnofsky performance status | 70.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Medications taken | 51.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Length of chemotherapy cycle | 46.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Planned relative dose intensity | 39.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Patient lives far from clinic/healthcare resources | 36.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of intensive chemotherapy | 28.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Estimated compliance with the treatment plan | 27.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Local access to reimbursed G-CSF PP | 26.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of G-CSFs in general | 24.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Outpatient care of the patient | 21.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Hospitalized patient | 16.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Family/caregiver/nurse support to the patient | 13.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Retired vs employed/active status of the patient | 10.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Wait and see approach | 9.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Private health insurance of the patient | 7.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty | Other | 0 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
Time frame: Assessed at baseline, prior to participant enrolment.
Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 91.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 77.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Age | 75.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Guidelines | 71.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 67.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 66.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 57.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Medications taken | 48.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | 38.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 33.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 29.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 22.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 21.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 19.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | 18.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 17.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 14.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | 8.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 8.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | 6.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Other | 0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 43.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 84.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 15.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 71.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 15.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Age | 89.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 15.0 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Guidelines | 65.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 38.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 73.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Other | 2.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 71.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 23.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 47.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | 4.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Medications taken | 51.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | 19.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | 25.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | 8.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 30.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 19.6 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
Time frame: Assessed at baseline, prior to participant enrolment.
Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 77.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Private health insurance of the patient | 12.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 69.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outpatient care of the patient | 20.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 64.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Wait and see approach | 10.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 56.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Hospitalized patient | 20.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Length of chemotherapy cycle | 56.0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other | 0 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 48.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of G-CSFs in general | 24.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of intensive chemotherapy | 41.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outcome of the overall FN risk assessment | 85.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Patient lives far from clinic/healthcare resources | 39.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Retired vs employed/active status of the patient | 14.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 35.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 79.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Local access to reimbursed G-CSF PP | 29.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Family/caregiver/nurse support to the patient | 20.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Estimated compliance with the treatment plan | 29.1 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 71.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of G-CSFs in general | 18.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outpatient care of the patient | 20.6 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Family/caregiver/nurse support to the patient | 11.5 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Hospitalized patient | 15.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Retired vs employed/active status of the patient | 6.6 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Private health insurance of the patient | 4.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Wait and see approach | 10.3 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other | 0.9 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outcome of the overall FN risk assessment | 90.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 79.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 66.8 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 74.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Estimated compliance with the treatment plan | 22.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 69.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Length of chemotherapy cycle | 46.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 51.2 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of intensive chemotherapy | 27.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Patient lives far from clinic/healthcare resources | 32.4 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 33.7 percentage of investigators |
| > 10 Years | Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Local access to reimbursed G-CSF PP | 20.7 percentage of investigators |
Secondary
Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: Assessed at baseline, prior to participant enrolment.
Population: Primary analysis set - investigators
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Outcome of the overall FN risk assessment | 88.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Age | 79.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Baseline laboratory values | 73.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Guidelines | 70.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Treatment intent | 69.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | ECOG/Karnofsky performance status | 66.1 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Medications taken | 50.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Length of chemotherapy cycle | 49.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Planned relative dose intensity | 34.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Patient lives far from clinic/healthcare resources | 33.8 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Safety risk of intensive chemotherapy | 30.9 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Estimated compliance with the treatment plan | 23.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Local access to reimbursed G-CSF PP | 22.7 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Outpatient care of the patient | 20.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Safety risk of G-CSFs in general | 19.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Hospitalized patient | 16.3 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Family/caregiver/nurse support to the patient | 13.6 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Wait and see approach | 10.2 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Retired vs employed/active status of the patient | 8.5 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Private health insurance of the patient | 6.4 percentage of investigators |
| Primary Analysis Set - Investigators | Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Other | 0.6 percentage of investigators |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Outcome of the overall FN risk assessment | 79.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Guidelines | 72.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Treatment intent | 69.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Age | 50.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | ECOG/Karnofsky performance status | 37.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Baseline laboratory values | 19.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Length of chemotherapy cycle | 10.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Planned relative dose intensity | 10.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Outpatient care of the patient | 7.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Patient lives far from clinic/healthcare resources | 9.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Medications taken | 4.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Estimated compliance with the treatment plan | 4.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of G-CSFs in general | 4.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Local access to reimbursed G-CSF PP | 4.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Family/caregiver/nurse support to the patient | 2.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Retired vs employed/active status of the patient | 3.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Hospitalized patient | 1.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of intensive chemotherapy | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Wait and see approach | 2.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Private health insurance of the patient | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Other | 0.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Medications taken | 17.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Outcome of the overall FN risk assessment | 78.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Wait and see approach | 3.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Guidelines | 33.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Estimated compliance with the treatment plan | 8.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Treatment intent | 65.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Hospitalized patient | 5.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Age | 74.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of G-CSFs in general | 4.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | ECOG/Karnofsky performance status | 40.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Other | 1.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Baseline laboratory values | 25.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Local access to reimbursed G-CSF PP | 4.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Length of chemotherapy cycle | 24.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Safety risk of intensive chemotherapy | 3.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Planned relative dose intensity | 18.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Family/caregiver/nurse support to the patient | 5.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Outpatient care of the patient | 16.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Private health insurance of the patient | 0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Patient lives far from clinic/healthcare resources | 8.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty | Retired vs employed/active status of the patient | 4.7 percentage of participants |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outcome of the overall FN risk assessment | 53.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Guidelines | 79.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Treatment intent | 62.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Age | 59.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | ECOG/Karnofsky performance status | 69.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Baseline laboratory values | 23.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Length of chemotherapy cycle | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Planned relative dose intensity | 6.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outpatient care of the patient | 3.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Patient lives far from clinic/healthcare resources | 2.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Medications taken | 3.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Estimated compliance with the treatment plan | 1.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of G-CSFs in general | 5.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Local access to reimbursed G-CSF PP | 2.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Family/caregiver/nurse support to the patient | 0.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Retired vs employed/active status of the patient | 1.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Hospitalized patient | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of intensive chemotherapy | 1.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Wait and see approach | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Private health insurance of the patient | 1.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Other | 0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of intensive chemotherapy | 1.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outcome of the overall FN risk assessment | 60.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Planned relative dose intensity | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Estimated compliance with the treatment plan | 3.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Length of chemotherapy cycle | 20.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Retired vs employed/active status of the patient | 5.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Family/caregiver/nurse support to the patient | 3.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of G-CSFs in general | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Treatment intent | 46.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Private health insurance of the patient | 1.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Hospitalized patient | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Local access to reimbursed G-CSF PP | 1.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outpatient care of the patient | 21.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | ECOG/Karnofsky performance status | 39.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Baseline laboratory values | 9.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Other | 0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Patient lives far from clinic/healthcare resources | 14.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Age | 57.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Guidelines | 39.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Wait and see approach | 4.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Medications taken | 3.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Guidelines | 87.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Baseline laboratory values | 39.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Length of chemotherapy cycle | 25.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of intensive chemotherapy | 0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Planned relative dose intensity | 11.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outpatient care of the patient | 10.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Patient lives far from clinic/healthcare resources | 23.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Medications taken | 8.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Wait and see approach | 0.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Estimated compliance with the treatment plan | 8.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of G-CSFs in general | 0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Other | 0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Local access to reimbursed G-CSF PP | 15.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Family/caregiver/nurse support to the patient | 4.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Private health insurance of the patient | 0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Retired vs employed/active status of the patient | 5.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outcome of the overall FN risk assessment | 91.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Treatment intent | 81.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Hospitalized patient | 5.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Age | 54.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | ECOG/Karnofsky performance status | 34.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Retired vs employed/active status of the patient | 2.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Medications taken | 10.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Hospitalized patient | NA percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outcome of the overall FN risk assessment | 74.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Private health insurance of the patient | 0.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Patient lives far from clinic/healthcare resources | 3.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Outpatient care of the patient | 2.3 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Guidelines | 82.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of intensive chemotherapy | 2.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Planned relative dose intensity | 3.7 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Baseline laboratory values | 4.3 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Treatment intent | 64.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Other | 1.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Local access to reimbursed G-CSF PP | 1.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Safety risk of G-CSFs in general | 2.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Wait and see approach | 0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Length of chemotherapy cycle | 5.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Family/caregiver/nurse support to the patient | 4.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | ECOG/Karnofsky performance status | 30.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Estimated compliance with the treatment plan | 7.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country | Age | 38.0 percentage of participants |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 78.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Guidelines | 68.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 71.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Age | 41.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 29.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 18.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 26.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 13.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 5.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 6.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Medications taken | 7.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 5.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 1.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 3.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | 2.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 2.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | 1.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 0.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | 0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Other | 0.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | 2.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 73.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 7.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 4.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 13.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | 3.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 3.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | 5.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 67.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | 1.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 1.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 9.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 11.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 39.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 16.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Other | 0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 11.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Age | 58.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Guidelines | 65.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 1.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Medications taken | 7.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Guidelines | 82.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 13.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 4.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 8.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 11.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 6.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Medications taken | 5.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 2.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 5.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Other | 0.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 2.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 2.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | 1.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | 3.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 90.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 63.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 2.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Age | 52.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 35.2 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Retired vs employed/active status of the patient | NA percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Medications taken | 6.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Hospitalized patient | 1.3 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outcome of the overall FN risk assessment | 62.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Private health insurance of the patient | NA percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Patient lives far from clinic/healthcare resources | 2.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Outpatient care of the patient | 4.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Guidelines | 41.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of intensive chemotherapy | 3.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Planned relative dose intensity | 8.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Baseline laboratory values | 29.9 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Treatment intent | 62.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Other | 0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Local access to reimbursed G-CSF PP | 1.7 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Safety risk of G-CSFs in general | 9.7 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Wait and see approach | 3.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Length of chemotherapy cycle | 7.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Family/caregiver/nurse support to the patient | 1.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | ECOG/Karnofsky performance status | 53.3 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Estimated compliance with the treatment plan | 3.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type | Age | 67.3 percentage of participants |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outcome of the overall FN risk assessment | 76.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 59.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 57.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 55.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 28.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 14.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Length of chemotherapy cycle | 16.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 7.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outpatient care of the patient | 10.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Patient lives far from clinic/healthcare resources | 5.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 4.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Estimated compliance with the treatment plan | 4.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of G-CSFs in general | 3.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Local access to reimbursed G-CSF PP | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Family/caregiver/nurse support to the patient | 6.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Retired vs employed/active status of the patient | 3.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Hospitalized patient | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of intensive chemotherapy | 1.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Wait and see approach | 1.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Private health insurance of the patient | 0.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other | 0.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 7.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outcome of the overall FN risk assessment | 76.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Wait and see approach | 2.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 65.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Estimated compliance with the treatment plan | 5.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 71.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Hospitalized patient | 2.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 50.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of G-CSFs in general | 4.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 40.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 18.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Local access to reimbursed G-CSF PP | 3.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Length of chemotherapy cycle | 12.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Safety risk of intensive chemotherapy | 2.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 9.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Family/caregiver/nurse support to the patient | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Outpatient care of the patient | 8.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Private health insurance of the patient | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Patient lives far from clinic/healthcare resources | 8.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology | Retired vs employed/active status of the patient | 3.1 percentage of participants |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type
For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Estimated compliance with the treatment plan | 5.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Treatment intent | 68.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Retired vs employed/active status of the patient | 3.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Other | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of G-CSFs in general | 5.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Private health insurance of the patient | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outpatient care of the patient | 7.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Family/caregiver/nurse support to the patient | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Local access to reimbursed G-CSF PP | 5.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Guidelines | 75.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Age | 39.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Length of chemotherapy cycle | 10.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Patient lives far from clinic/healthcare resources | 7.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Wait and see approach | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | ECOG/Karnofsky performance status | 25.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outcome of the overall FN risk assessment | 81.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of intensive chemotherapy | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Planned relative dose intensity | 9.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Baseline laboratory values | 16.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Medications taken | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Hospitalized patient | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Treatment intent | 66.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Guidelines | 59.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Medications taken | 4.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Age | 56.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | ECOG/Karnofsky performance status | 49.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Baseline laboratory values | 24.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Estimated compliance with the treatment plan | 4.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Planned relative dose intensity | 7.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of G-CSFs in general | 2.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Local access to reimbursed G-CSF PP | 6.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Length of chemotherapy cycle | 16.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Family/caregiver/nurse support to the patient | 3.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Retired vs employed/active status of the patient | 2.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outpatient care of the patient | 12.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Hospitalized patient | 4.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of intensive chemotherapy | 0.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Wait and see approach | 3.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Private health insurance of the patient | 2.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Patient lives far from clinic/healthcare resources | 8.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Other | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outcome of the overall FN risk assessment | 64.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Patient lives far from clinic/healthcare resources | 8.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Hospitalized patient | 4.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outpatient care of the patient | 10.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | ECOG/Karnofsky performance status | 42.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outcome of the overall FN risk assessment | 78.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of intensive chemotherapy | 3.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Length of chemotherapy cycle | 16.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Medications taken | 15.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Guidelines | 45.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Wait and see approach | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Local access to reimbursed G-CSF PP | 5.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Age | 69.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Planned relative dose intensity | 18.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Treatment intent | 60.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Family/caregiver/nurse support to the patient | 4.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of G-CSFs in general | 5.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Estimated compliance with the treatment plan | 7.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Other | 0.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Retired vs employed/active status of the patient | 4.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Private health insurance of the patient | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Baseline laboratory values | 29.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Wait and see approach | 2.9 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Length of chemotherapy cycle | 14.5 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Planned relative dose intensity | 13.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outpatient care of the patient | 10.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Patient lives far from clinic/healthcare resources | 5.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Medications taken | 7.9 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Estimated compliance with the treatment plan | 5.0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of G-CSFs in general | 5.2 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Local access to reimbursed G-CSF PP | 7.4 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Family/caregiver/nurse support to the patient | NA percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Retired vs employed/active status of the patient | 3.9 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Hospitalized patient | 1.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Safety risk of intensive chemotherapy | 2.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Baseline laboratory values | 9.7 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Private health insurance of the patient | 1.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Other | 0 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Outcome of the overall FN risk assessment | 62.6 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Guidelines | 59.8 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Treatment intent | 62.7 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | Age | 45.1 percentage of participants |
| France | Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type | ECOG/Karnofsky performance status | 44.0 percentage of participants |
Secondary
Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important
For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Outcome of the overall FN risk assessment | 78.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Guidelines | 67.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Treatment intent | 67.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Age | 51.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | ECOG/Karnofsky performance status | 36.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Baseline laboratory values | 18.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Length of chemotherapy cycle | 13.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Planned relative dose intensity | 9.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Outpatient care of the patient | 8.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Patient lives far from clinic/healthcare resources | 7.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Medications taken | 6.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Estimated compliance with the treatment plan | 4.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Safety risk of G-CSFs in general | 4.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Local access to reimbursed G-CSF PP | 3.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Family/caregiver/nurse support to the patient | 3.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Retired vs employed/active status of the patient | 3.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Hospitalized patient | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Safety risk of intensive chemotherapy | 2.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Wait and see approach | 1.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Private health insurance of the patient | 1.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important | Other | 0.4 percentage of participants |
Secondary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Chemotherapy agents in the backbone | 93.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Tumor type | 72.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Guidelines | 71.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Tumor stage | 49.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Age | 40.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Treatment intent | 30.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | ECOG/Karnofsky performance status | 30.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Female gender | 22.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Comorbidities | 13.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Baseline laboratory values | 15.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Personal experience of chemotherapy regimen risk | 17.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Prior chemotherapy | 15.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Nutritional status | 7.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Planned relative dose intensity | 7.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Medications taken | 4.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | History of prior FN | 3.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Documented bone marrow involvement | 2.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Prior radiotherapy involving bone marrow | 4.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Current infection | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Concurrent radiotherapy | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Open wounds | 2.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Other patient related | 1.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Other disease/treatment related | 1.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Prior chemotherapy | 14.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Chemotherapy agents in the backbone | 93.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Prior radiotherapy involving bone marrow | 2.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Tumor type | 81.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Nutritional status | 13.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Guidelines | 27.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Open wounds | 2.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Tumor stage | 42.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Planned relative dose intensity | 9.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Age | 55.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Current infection | 9.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Treatment intent | 39.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Medications taken | 11.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | ECOG/Karnofsky performance status | 28.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Other disease/treatment related | 0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Female gender | 13.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | History of prior FN | 5.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Comorbidities | 27.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Concurrent radiotherapy | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Baseline laboratory values | 24.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Documented bone marrow involvement | 20.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Personal experience of chemotherapy regimen risk | 10.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty | Other patient related | 4.4 percentage of participants |
Secondary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; analysis only includes subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Chemotherapy agents in the backbone | 81.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior radiotherapy involving bone marrow | 5.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Nutritional status | 9.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor stage | 47.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Planned relative dose intensity | 4.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Documented bone marrow involvement | 1.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Medications taken | 1.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor type | 67.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | History of prior FN | 4.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other patient related | 0.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Age | 50.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Treatment intent | 15.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Open wounds | 1.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | ECOG/Karnofsky performance status | 57.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other disease/treatment related | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Female gender | 28.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Guidelines | 85.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Concurrent radiotherapy | 2.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Comorbidities | 18.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Baseline laboratory values | 18.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Current infection | 2.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Personal experience of chemotherapy regimen risk | 4.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior chemotherapy | 14.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Current infection | 4.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other patient related | 1.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | ECOG/Karnofsky performance status | 29.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Nutritional status | 2.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Baseline laboratory values | 7.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Documented bone marrow involvement | 8.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Concurrent radiotherapy | 5.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Planned relative dose intensity | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor stage | 39.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other disease/treatment related | 0.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Female gender | 4.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Medications taken | 4.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior radiotherapy involving bone marrow | 3.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | History of prior FN | 2.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior chemotherapy | 12.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Personal experience of chemotherapy regimen risk | 19.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Comorbidities | 18.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Age | 45.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor type | 61.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Open wounds | 0.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Guidelines | 44.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Treatment intent | 24.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Chemotherapy agents in the backbone | 96.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior chemotherapy | 28.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Chemotherapy agents in the backbone | 98.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor type | 95.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Guidelines | 91.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor stage | 69.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Age | 33.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Treatment intent | 52.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | ECOG/Karnofsky performance status | 23.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Female gender | 38.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Comorbidities | 29.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Baseline laboratory values | 27.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Personal experience of chemotherapy regimen risk | 11.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Nutritional status | 12.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Planned relative dose intensity | 12.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Medications taken | 5.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | History of prior FN | 7.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Documented bone marrow involvement | 2.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior radiotherapy involving bone marrow | 3.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Current infection | 3.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Concurrent radiotherapy | 0.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Open wounds | 1.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other patient related | 2.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other disease/treatment related | 0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Personal experience of chemotherapy regimen risk | 26.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other disease/treatment related | 0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior radiotherapy involving bone marrow | 1.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Baseline laboratory values | 7.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Comorbidities | 6.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Other patient related | 1.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Current infection | 1.0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Female gender | 8.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | ECOG/Karnofsky performance status | 19.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor type | 67.9 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Concurrent radiotherapy | 3.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Treatment intent | 16.9 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Age | 13.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Chemotherapy agents in the backbone | 88.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Open wounds | 0.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Medications taken | 4.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Tumor stage | 24.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | History of prior FN | 4.0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Planned relative dose intensity | 3.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Nutritional status | 10.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Guidelines | 62.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Documented bone marrow involvement | 2.1 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country | Prior chemotherapy | 10.7 percentage of participants |
Secondary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Chemotherapy agents in the backbone | 95.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior radiotherapy involving bone marrow | 3.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Nutritional status | 8.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor stage | 37.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Planned relative dose intensity | 10.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Documented bone marrow involvement | 6.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Medications taken | 6.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor type | 66.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | History of prior FN | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other patient related | 3.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Age | 33.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Treatment intent | 32.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Open wounds | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | ECOG/Karnofsky performance status | 20.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other disease/treatment related | 0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Female gender | 14.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Guidelines | 51.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Concurrent radiotherapy | 1.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Comorbidities | 14.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Baseline laboratory values | 20.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Current infection | 4.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Personal experience of chemotherapy regimen risk | 9.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior chemotherapy | 15.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Current infection | 2.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other patient related | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | ECOG/Karnofsky performance status | 31.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Nutritional status | 11.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Baseline laboratory values | 12.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Documented bone marrow involvement | 5.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Concurrent radiotherapy | 2.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Planned relative dose intensity | 6.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor stage | 51.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other disease/treatment related | 1.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Female gender | 15.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Medications taken | 7.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior radiotherapy involving bone marrow | 2.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | History of prior FN | 3.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior chemotherapy | 13.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Personal experience of chemotherapy regimen risk | 15.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Comorbidities | 13.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Age | 37.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor type | 81.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Open wounds | 1.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Guidelines | 64.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Treatment intent | 33.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Chemotherapy agents in the backbone | 92.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior chemotherapy | 12.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Chemotherapy agents in the backbone | 91.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor type | 68.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Guidelines | 74.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor stage | 36.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Age | 45.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Treatment intent | 33.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | ECOG/Karnofsky performance status | 29.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Female gender | 22.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Comorbidities | 17.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Baseline laboratory values | 10.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Personal experience of chemotherapy regimen risk | 37.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Nutritional status | 5.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Planned relative dose intensity | 4.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Medications taken | 2.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | History of prior FN | 5.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Documented bone marrow involvement | 3.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior radiotherapy involving bone marrow | 5.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Current infection | 3.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Concurrent radiotherapy | 3.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Open wounds | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other patient related | 2.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other disease/treatment related | 0.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Personal experience of chemotherapy regimen risk | 4.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other disease/treatment related | 1.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior radiotherapy involving bone marrow | 4.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Baseline laboratory values | 22.1 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Comorbidities | 17.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Other patient related | 1.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Current infection | 2.9 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Female gender | 25.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | ECOG/Karnofsky performance status | 42.1 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor type | 74.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Concurrent radiotherapy | 2.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Treatment intent | 17.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Age | 50.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Chemotherapy agents in the backbone | 86.1 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Open wounds | 3.0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Medications taken | 3.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Tumor stage | 44.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | History of prior FN | 3.9 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Planned relative dose intensity | 7.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Nutritional status | 5.9 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Guidelines | 54.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Documented bone marrow involvement | 0.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type | Prior chemotherapy | 18.5 percentage of participants |
Secondary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Chemotherapy agents in the backbone | 91.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Tumor type | 59.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 55.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Tumor stage | 34.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 35.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 26.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 23.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Female gender | 12.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Comorbidities | 14.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 12.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Personal experience of chemotherapy regimen risk | 15.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Prior chemotherapy | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Nutritional status | 5.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 5.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 5.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | History of prior FN | 2.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Documented bone marrow involvement | 3.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Prior radiotherapy involving bone marrow | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Current infection | 1.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Concurrent radiotherapy | 3.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Open wounds | 0.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other patient related | 2.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other disease/treatment related | 1.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Prior chemotherapy | 15.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Chemotherapy agents in the backbone | 92.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Prior radiotherapy involving bone marrow | 4.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Tumor type | 76.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Nutritional status | 9.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Guidelines | 60.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Open wounds | 2.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Tumor stage | 45.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Planned relative dose intensity | 7.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Age | 41.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Current infection | 4.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Treatment intent | 32.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Medications taken | 5.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | ECOG/Karnofsky performance status | 31.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other disease/treatment related | 0.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Female gender | 21.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | History of prior FN | 5.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Comorbidities | 16.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Concurrent radiotherapy | 2.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Baseline laboratory values | 15.5 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Documented bone marrow involvement | 4.8 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Personal experience of chemotherapy regimen risk | 15.1 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology | Other patient related | NA percentage of participants |
Secondary
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
Time frame: At enrolment, prior to chemotherapy initiation.
Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Chemotherapy agents in the backbone | 93.8 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior radiotherapy involving bone marrow | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Nutritional status | 4.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor stage | 38.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Planned relative dose intensity | 7.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Documented bone marrow involvement | 1.5 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Medications taken | 3.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor type | 64.9 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | History of prior FN | 4.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other patient related | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Age | 31.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Treatment intent | 34.0 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Open wounds | 2.7 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | ECOG/Karnofsky performance status | 21.1 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other disease/treatment related | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Female gender | 34.3 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Guidelines | 68.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Concurrent radiotherapy | 1.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Comorbidities | 10.6 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Baseline laboratory values | 13.2 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Current infection | NA percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Personal experience of chemotherapy regimen risk | 21.4 percentage of participants |
| Primary Analysis Set - Investigators | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior chemotherapy | 12.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Current infection | 3.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other patient related | 2.6 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | ECOG/Karnofsky performance status | 40.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Nutritional status | 13.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Baseline laboratory values | 15.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Documented bone marrow involvement | 2.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Concurrent radiotherapy | 2.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Planned relative dose intensity | 5.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor stage | 57.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other disease/treatment related | NA percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Female gender | 8.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Medications taken | 3.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior radiotherapy involving bone marrow | 5.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | History of prior FN | 3.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior chemotherapy | 17.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Personal experience of chemotherapy regimen risk | 16.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Comorbidities | 18.0 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Age | 42.3 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor type | 75.9 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Open wounds | 1.4 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Guidelines | 62.7 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Treatment intent | 25.2 percentage of participants |
| > 10 Years | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Chemotherapy agents in the backbone | 85.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior chemotherapy | 14.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Chemotherapy agents in the backbone | 90.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor type | 77.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Guidelines | 43.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor stage | 39.7 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Age | 56.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Treatment intent | 35.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | ECOG/Karnofsky performance status | 32.6 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Female gender | 13.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Comorbidities | 25.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Baseline laboratory values | 21.9 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Personal experience of chemotherapy regimen risk | 14.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Nutritional status | 14.3 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Planned relative dose intensity | 10.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Medications taken | 11.1 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | History of prior FN | 7.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Documented bone marrow involvement | 19.4 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior radiotherapy involving bone marrow | 2.2 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Current infection | 8.8 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Concurrent radiotherapy | NA percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Open wounds | 3.5 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other patient related | 5.0 percentage of participants |
| Romania | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other disease/treatment related | 1.1 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Personal experience of chemotherapy regimen risk | 22.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other disease/treatment related | 2.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior radiotherapy involving bone marrow | 3.4 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Baseline laboratory values | 10.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Comorbidities | 17.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Other patient related | 2.6 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Current infection | NA percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Female gender | 6.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | ECOG/Karnofsky performance status | 37.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor type | 64.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Concurrent radiotherapy | 10.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Treatment intent | 22.2 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Age | 33.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Chemotherapy agents in the backbone | 80.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Open wounds | NA percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Medications taken | 5.5 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Tumor stage | 64.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | History of prior FN | 2.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Planned relative dose intensity | 10.8 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Nutritional status | 11.0 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Guidelines | 56.3 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Documented bone marrow involvement | 1.7 percentage of participants |
| France | Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type | Prior chemotherapy | 15.1 percentage of participants |
Secondary
Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP
At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.
Time frame: At Baseline and at enrolment, prior to chemotherapy initiation.
Population: Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Set - Investigators | Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP | 82.0 percentage of participants |