Trial Outcomes & Findings for Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy. (NCT NCT01813721)
NCT ID: NCT01813721
Last Updated: 2017-03-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1007 participants
Primary outcome timeframe
Baseline (prior to participant enrolment)
Results posted on
2017-03-15
Participant Flow
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).
Participant milestones
| Measure |
All Enrolled Patients
Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
|
|---|---|
|
Overall Study
STARTED
|
1007
|
|
Overall Study
COMPLETED
|
943
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
All Enrolled Patients
Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
|
|---|---|
|
Overall Study
Ineligibility determined
|
63
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Baseline characteristics by cohort
| Measure |
Primary Analysis Set
n=944 Participants
|
|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
554 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
390 Participants
n=5 Participants
|
|
Tumor Type
Breast cancer
|
395 participants
n=5 Participants
|
|
Tumor Type
Non-small cell lung cancer (NSCLC)
|
248 participants
n=5 Participants
|
|
Tumor Type
Non-Hodgkin's lymphoma (NHL)
|
182 participants
n=5 Participants
|
|
Tumor Type
Small-cell lung cancer (SCLC)
|
119 participants
n=5 Participants
|
|
Investigator Specialty
Medical Oncologist
|
110 investigators
n=5 Participants
|
|
Investigator Specialty
Hematologist
|
31 investigators
n=5 Participants
|
|
Investigator Specialty
Pulmonologist
|
10 investigators
n=5 Participants
|
|
Investigator Specialty
Radiation Oncologist
|
8 investigators
n=5 Participants
|
|
Investigator Specialty
Medical Gynecologist
|
4 investigators
n=5 Participants
|
|
Investigator Specialty
Gynecological Surgeon
|
2 investigators
n=5 Participants
|
|
Number of years in oncology/hematology clinical practice
> 10 years
|
117 investigators
n=5 Participants
|
|
Number of years in oncology/hematology clinical practice
≤ 10 years
|
48 investigators
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to participant enrolment)Population: Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=165 Investigators
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Age
|
73.4 percentage of investigators
Interval 64.4 to 80.8
|
—
|
—
|
—
|
|
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
Interval 81.7 to 92.7
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Anthracyclines
|
41.1 percentage of investigators
Interval 31.6 to 51.3
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Taxanes
|
25.0 percentage of investigators
Interval 17.7 to 34.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Platinum(s)
|
22.2 percentage of investigators
Interval 15.1 to 31.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Alkylating agents
|
21.5 percentage of investigators
Interval 14.7 to 30.3
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Topoisomerase II inhibitors
|
13.8 percentage of investigators
Interval 8.8 to 21.2
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Topoisomerase I inhibitors
|
11.2 percentage of investigators
Interval 6.8 to 17.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Gemcitabine
|
9.7 percentage of investigators
Interval 5.9 to 15.7
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Vinorelbine
|
9.1 percentage of investigators
Interval 5.4 to 14.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
Other agents
|
2.4 percentage of investigators
Interval 0.9 to 6.4
|
—
|
—
|
—
|
|
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
Interval 57.0 to 74.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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).
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
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=165 Investigators
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Medications taken
|
47.9 percentage of investigators
Interval 38.2 to 57.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Current infection
|
45.4 percentage of investigators
Interval 36.6 to 54.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Concurrent radiotherapy
|
42.2 percentage of investigators
Interval 32.4 to 52.6
|
—
|
—
|
—
|
|
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
Interval 32.5 to 48.9
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Open wounds
|
37.0 percentage of investigators
Interval 27.7 to 47.3
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Planned relative dose intensity
|
25.5 percentage of investigators
Interval 18.2 to 34.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Female gender
|
23.2 percentage of investigators
Interval 15.7 to 32.9
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Other disease/treatment related
|
4.2 percentage of investigators
Interval 1.9 to 8.9
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Other patient related
|
2.4 percentage of investigators
Interval 0.9 to 6.4
|
—
|
—
|
—
|
|
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
Interval 81.7 to 92.7
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
History of prior FN
|
83.0 percentage of investigators
Interval 75.7 to 88.5
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Baseline laboratory values
|
76.2 percentage of investigators
Interval 67.9 to 82.9
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Age
|
73.4 percentage of investigators
Interval 64.4 to 80.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Prior chemotherapy
|
70.5 percentage of investigators
Interval 62.4 to 77.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Guidelines
|
69.9 percentage of investigators
Interval 60.0 to 78.2
|
—
|
—
|
—
|
|
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
Interval 55.6 to 73.0
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
ECOG/Karnofsky performance status
|
64.0 percentage of investigators
Interval 54.9 to 72.3
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Tumor type
|
62.7 percentage of investigators
Interval 53.0 to 71.5
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Comorbidities
|
62.5 percentage of investigators
Interval 53.5 to 70.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Documented bone marrow involvement
|
62.4 percentage of investigators
Interval 51.7 to 72.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Tumor stage
|
61.8 percentage of investigators
Interval 52.8 to 70.2
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Treatment intent
|
50.0 percentage of investigators
Interval 41.1 to 58.8
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
Nutritional status
|
49.2 percentage of investigators
Interval 40.2 to 58.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At enrolment, prior to chemotherapy initiationPopulation: 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.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=944 Participants
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Age
|
39.4 percentage of participants
Interval 31.9 to 47.5
|
—
|
—
|
—
|
|
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
Interval 88.0 to 95.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Anthracyclines
|
36.2 percentage of participants
Interval 25.6 to 48.4
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Taxanes
|
17.1 percentage of participants
Interval 11.6 to 24.3
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Platinum(s)
|
9.9 percentage of participants
Interval 6.4 to 15.1
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Alkylating agents
|
6.9 percentage of participants
Interval 4.4 to 10.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Topoisomerase II inhibitors
|
2.7 percentage of participants
Interval 1.7 to 4.3
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Vinorelbine
|
1.9 percentage of participants
Interval 1.1 to 3.4
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Topoisomerase I inhibitors
|
0.1 percentage of participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Gemcitabine
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor
Other agents
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=944 Participants
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Chemotherapy agents in the backbone
|
92.6 percentage of participants
Interval 88.0 to 95.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Tumor type
|
72.3 percentage of participants
Interval 60.7 to 81.5
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Guidelines
|
61.7 percentage of participants
Interval 48.1 to 73.8
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Tumor stage
|
42.9 percentage of participants
Interval 33.7 to 52.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Age
|
39.4 percentage of participants
Interval 31.9 to 47.5
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Treatment intent
|
30.9 percentage of participants
Interval 23.7 to 39.1
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
ECOG/Karnofsky performance status
|
27.8 percentage of participants
Interval 21.2 to 35.5
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Female gender
|
18.4 percentage of participants
Interval 12.7 to 25.7
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Comorbidities
|
15.6 percentage of participants
Interval 12.3 to 19.7
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Baseline laboratory values
|
15.3 percentage of participants
Interval 11.1 to 20.8
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Personal experience of chemotherapy regimen risk
|
15.2 percentage of participants
Interval 10.2 to 22.1
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Prior chemotherapy
|
14.8 percentage of participants
Interval 11.5 to 18.9
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Nutritional status
|
8.2 percentage of participants
Interval 5.8 to 11.5
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Planned relative dose intensity
|
7.1 percentage of participants
Interval 4.1 to 11.9
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Medications taken
|
5.2 percentage of participants
Interval 3.6 to 7.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
History of prior FN
|
4.4 percentage of participants
Interval 2.9 to 6.5
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Documented bone marrow involvement
|
4.3 percentage of participants
Interval 2.7 to 7.0
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Prior radiotherapy involving bone marrow
|
4.0 percentage of participants
Interval 2.8 to 5.7
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Current infection
|
3.7 percentage of participants
Interval 2.4 to 5.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Concurrent radiotherapy
|
2.3 percentage of participants
Interval 1.4 to 3.7
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Open wounds
|
2.2 percentage of participants
Interval 1.3 to 3.8
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Other patient related
|
2.0 percentage of participants
Interval 1.1 to 3.6
|
—
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important
Other disease/treatment related
|
0.8 percentage of participants
Interval 0.4 to 1.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline, prior to participant enrolment.Population: Primary analysis set - investigators
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=165 Investigators
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 82.6 to 92.9
|
—
|
—
|
—
|
|
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
Interval 70.6 to 86.5
|
—
|
—
|
—
|
|
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
Interval 64.3 to 81.5
|
—
|
—
|
—
|
|
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
Interval 61.2 to 78.3
|
—
|
—
|
—
|
|
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
Interval 60.8 to 76.8
|
—
|
—
|
—
|
|
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
Interval 56.2 to 74.8
|
—
|
—
|
—
|
|
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
Interval 40.8 to 60.7
|
—
|
—
|
—
|
|
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
Interval 39.0 to 60.3
|
—
|
—
|
—
|
|
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
Interval 25.6 to 44.0
|
—
|
—
|
—
|
|
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
Interval 25.4 to 43.3
|
—
|
—
|
—
|
|
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
Interval 22.7 to 40.4
|
—
|
—
|
—
|
|
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
Interval 16.8 to 32.3
|
—
|
—
|
—
|
|
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
Interval 15.4 to 32.1
|
—
|
—
|
—
|
|
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
Interval 14.5 to 28.1
|
—
|
—
|
—
|
|
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
Interval 13.0 to 28.0
|
—
|
—
|
—
|
|
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
Interval 10.8 to 24.0
|
—
|
—
|
—
|
|
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
Interval 8.3 to 21.3
|
—
|
—
|
—
|
|
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
Interval 6.3 to 16.2
|
—
|
—
|
—
|
|
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
Interval 4.9 to 14.4
|
—
|
—
|
—
|
|
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
Interval 3.3 to 12.0
|
—
|
—
|
—
|
|
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
Interval 0.1 to 4.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline, prior to participant enrolment.Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=110 Investigators
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 80.6 to 93.3
|
—
|
—
|
—
|
|
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
Interval 69.1 to 85.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
Age
|
77.7 percentage of investigators
Interval 66.6 to 86.0
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
Guidelines
|
75.5 percentage of investigators
Interval 65.2 to 83.5
|
—
|
—
|
—
|
|
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
Interval 61.5 to 83.1
|
—
|
—
|
—
|
|
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
Interval 58.2 to 80.4
|
—
|
—
|
—
|
|
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
Interval 39.2 to 63.9
|
—
|
—
|
—
|
|
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
Interval 34.7 to 58.4
|
—
|
—
|
—
|
|
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
Interval 28.8 to 51.6
|
—
|
—
|
—
|
|
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
Interval 25.7 to 48.7
|
—
|
—
|
—
|
|
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
Interval 19.4 to 40.7
|
—
|
—
|
—
|
|
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
Interval 18.3 to 38.2
|
—
|
—
|
—
|
|
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
Interval 16.4 to 38.7
|
—
|
—
|
—
|
|
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
Interval 15.2 to 36.0
|
—
|
—
|
—
|
|
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
Interval 14.6 to 31.5
|
—
|
—
|
—
|
|
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
Interval 9.6 to 26.7
|
—
|
—
|
—
|
|
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
Interval 7.7 to 23.4
|
—
|
—
|
—
|
|
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
Interval 5.9 to 18.5
|
—
|
—
|
—
|
|
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
Interval 4.8 to 16.4
|
—
|
—
|
—
|
|
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
Interval 3.4 to 14.2
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty
Other
|
0 percentage of investigators
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline, prior to participant enrolment.Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=48 Investigators
|
> 10 Years
n=117 Investigators
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 70.6 to 93.4
|
90.2 percentage of investigators
Interval 82.9 to 94.6
|
—
|
—
|
|
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
Interval 61.3 to 90.2
|
79.4 percentage of investigators
Interval 69.0 to 87.0
|
—
|
—
|
|
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
Interval 61.6 to 87.6
|
66.8 percentage of investigators
Interval 56.0 to 76.1
|
—
|
—
|
|
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
Interval 52.2 to 82.6
|
74.2 percentage of investigators
Interval 63.6 to 82.6
|
—
|
—
|
|
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
Interval 46.7 to 78.8
|
71.9 percentage of investigators
Interval 62.0 to 80.0
|
—
|
—
|
|
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
Interval 37.9 to 73.7
|
69.7 percentage of investigators
Interval 58.6 to 79.0
|
—
|
—
|
|
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
Interval 39.2 to 71.6
|
46.7 percentage of investigators
Interval 34.9 to 58.9
|
—
|
—
|
|
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
Interval 31.2 to 65.6
|
51.2 percentage of investigators
Interval 40.6 to 61.7
|
—
|
—
|
|
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
Interval 24.7 to 60.0
|
27.4 percentage of investigators
Interval 19.5 to 37.0
|
—
|
—
|
|
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
Interval 23.6 to 57.1
|
32.4 percentage of investigators
Interval 23.7 to 42.5
|
—
|
—
|
|
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
Interval 21.7 to 52.1
|
33.7 percentage of investigators
Interval 24.1 to 45.0
|
—
|
—
|
|
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
Interval 16.9 to 45.8
|
20.7 percentage of investigators
Interval 12.7 to 32.0
|
—
|
—
|
|
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
Interval 17.0 to 45.1
|
22.4 percentage of investigators
Interval 14.9 to 32.3
|
—
|
—
|
|
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
Interval 12.9 to 41.5
|
18.3 percentage of investigators
Interval 11.5 to 28.0
|
—
|
—
|
|
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
Interval 10.9 to 36.2
|
20.6 percentage of investigators
Interval 13.8 to 29.7
|
—
|
—
|
|
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
Interval 10.9 to 36.2
|
11.5 percentage of investigators
Interval 6.2 to 20.4
|
—
|
—
|
|
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
Interval 10.6 to 36.6
|
15.4 percentage of investigators
Interval 9.8 to 23.3
|
—
|
—
|
|
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
Interval 6.6 to 29.2
|
6.6 percentage of investigators
Interval 3.1 to 13.2
|
—
|
—
|
|
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
Interval 5.3 to 26.8
|
4.7 percentage of investigators
Interval 1.9 to 10.9
|
—
|
—
|
|
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
Interval 4.0 to 24.4
|
10.3 percentage of investigators
Interval 5.8 to 17.4
|
—
|
—
|
|
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
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0.9 percentage of investigators
Interval 0.1 to 6.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline, prior to participant enrolment.Population: Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=57 Investigators
|
> 10 Years
n=46 Investigators
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 79.2 to 97.2
|
84.8 percentage of investigators
Interval 70.4 to 92.9
|
—
|
—
|
|
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
Interval 56.5 to 90.1
|
71.8 percentage of investigators
Interval 54.4 to 84.5
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
Age
|
75.2 percentage of investigators
Interval 54.8 to 88.3
|
89.0 percentage of investigators
Interval 70.9 to 96.4
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
Guidelines
|
71.9 percentage of investigators
Interval 50.2 to 86.7
|
65.1 percentage of investigators
Interval 46.5 to 80.0
|
—
|
—
|
|
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
Interval 45.6 to 83.1
|
73.9 percentage of investigators
Interval 58.6 to 85.0
|
—
|
—
|
|
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
Interval 50.4 to 79.2
|
71.5 percentage of investigators
Interval 45.9 to 88.1
|
—
|
—
|
|
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
Interval 36.2 to 76.5
|
47.7 percentage of investigators
Interval 31.2 to 64.8
|
—
|
—
|
|
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
Interval 27.8 to 69.2
|
51.3 percentage of investigators
Interval 34.4 to 67.9
|
—
|
—
|
|
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
Interval 20.5 to 59.6
|
25.9 percentage of investigators
Interval 13.9 to 43.1
|
—
|
—
|
|
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
Interval 20.3 to 50.7
|
30.7 percentage of investigators
Interval 15.0 to 52.6
|
—
|
—
|
|
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
Interval 15.9 to 49.1
|
43.2 percentage of investigators
Interval 28.2 to 59.5
|
—
|
—
|
|
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
Interval 11.9 to 38.4
|
15.2 percentage of investigators
Interval 7.1 to 29.6
|
—
|
—
|
|
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
Interval 10.8 to 37.3
|
38.3 percentage of investigators
Interval 19.8 to 61.0
|
—
|
—
|
|
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
Interval 9.1 to 38.3
|
23.9 percentage of investigators
Interval 13.3 to 39.1
|
—
|
—
|
|
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
Interval 8.7 to 35.8
|
19.5 percentage of investigators
Interval 7.8 to 40.9
|
—
|
—
|
|
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
Interval 7.9 to 34.8
|
19.6 percentage of investigators
Interval 10.1 to 34.4
|
—
|
—
|
|
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
Interval 5.9 to 31.4
|
15.0 percentage of investigators
Interval 6.5 to 31.1
|
—
|
—
|
|
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
Interval 2.9 to 22.7
|
4.3 percentage of investigators
Interval 1.0 to 16.9
|
—
|
—
|
|
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
Interval 2.8 to 20.9
|
15.2 percentage of investigators
Interval 7.1 to 29.6
|
—
|
—
|
|
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
Interval 1.8 to 18.1
|
8.4 percentage of investigators
Interval 2.4 to 25.7
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type
Other
|
0 percentage of investigators
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
2.2 percentage of investigators
Interval 0.3 to 15.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=944 Participants
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 71.4 to 84.3
|
—
|
—
|
—
|
|
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
Interval 53.4 to 78.9
|
—
|
—
|
—
|
|
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
Interval 59.0 to 74.3
|
—
|
—
|
—
|
|
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
Interval 42.9 to 59.8
|
—
|
—
|
—
|
|
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
Interval 27.8 to 45.4
|
—
|
—
|
—
|
|
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
Interval 12.9 to 24.8
|
—
|
—
|
—
|
|
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
Interval 8.5 to 20.1
|
—
|
—
|
—
|
|
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
Interval 5.7 to 15.8
|
—
|
—
|
—
|
|
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
Interval 5.3 to 13.1
|
—
|
—
|
—
|
|
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
Interval 4.7 to 11.0
|
—
|
—
|
—
|
|
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
Interval 4.4 to 10.5
|
—
|
—
|
—
|
|
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
Interval 2.9 to 8.0
|
—
|
—
|
—
|
|
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
Interval 2.5 to 6.1
|
—
|
—
|
—
|
|
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
Interval 1.7 to 6.6
|
—
|
—
|
—
|
|
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
Interval 1.8 to 5.3
|
—
|
—
|
—
|
|
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
Interval 1.9 to 4.9
|
—
|
—
|
—
|
|
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
Interval 1.3 to 4.0
|
—
|
—
|
—
|
|
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
Interval 1.2 to 3.6
|
—
|
—
|
—
|
|
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
Interval 1.0 to 3.3
|
—
|
—
|
—
|
|
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
Interval 0.5 to 2.0
|
—
|
—
|
—
|
|
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
Interval 0.1 to 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=205 Participants
|
> 10 Years
n=173 Participants
|
Romania
n=141 Participants
|
France
n=126 Participants
|
|---|---|---|---|---|
|
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
Interval 30.4 to 74.7
|
60.3 percentage of participants
Interval 33.3 to 82.2
|
91.2 percentage of participants
Interval 82.4 to 95.8
|
74.5 percentage of participants
Interval 64.0 to 82.8
|
|
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
Interval 38.1 to 96.2
|
39.5 percentage of participants
Interval 13.8 to 72.7
|
87.2 percentage of participants
Interval 56.6 to 97.3
|
82.5 percentage of participants
Interval 40.1 to 97.1
|
|
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
Interval 35.3 to 83.7
|
46.8 percentage of participants
Interval 27.9 to 66.7
|
81.0 percentage of participants
Interval 59.1 to 92.6
|
64.6 percentage of participants
Interval 42.3 to 81.9
|
|
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
Interval 40.8 to 76.4
|
57.8 percentage of participants
Interval 36.2 to 76.8
|
54.2 percentage of participants
Interval 28.1 to 78.2
|
38.0 percentage of participants
Interval 20.9 to 58.6
|
|
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
Interval 37.0 to 89.7
|
39.7 percentage of participants
Interval 20.7 to 62.5
|
34.6 percentage of participants
Interval 12.3 to 66.5
|
30.1 percentage of participants
Interval 18.4 to 45.1
|
|
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
Interval 11.3 to 41.5
|
9.7 percentage of participants
Interval 3.3 to 25.2
|
39.0 percentage of participants
Interval 20.9 to 60.7
|
4.3 percentage of participants
Interval 0.9 to 18.9
|
|
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
Interval 1.7 to 8.4
|
20.0 percentage of participants
Interval 5.6 to 51.5
|
25.8 percentage of participants
Interval 8.2 to 57.4
|
5.6 percentage of participants
Interval 1.1 to 24.9
|
|
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
Interval 2.8 to 15.4
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
11.3 percentage of participants
Interval 1.7 to 48.7
|
3.7 percentage of participants
Interval 0.8 to 15.9
|
|
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
Interval 1.4 to 8.5
|
21.7 percentage of participants
Interval 6.0 to 54.4
|
10.9 percentage of participants
Interval 3.4 to 30.0
|
2.3 percentage of participants
Interval 0.3 to 14.9
|
|
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
Interval 1.0 to 6.2
|
14.3 percentage of participants
Interval 8.0 to 24.3
|
23.7 percentage of participants
Interval 10.7 to 44.5
|
3.5 percentage of participants
Interval 1.1 to 11.2
|
|
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
Interval 1.4 to 9.0
|
3.6 percentage of participants
Interval 1.0 to 11.9
|
8.0 percentage of participants
Interval 2.4 to 24.0
|
10.0 percentage of participants
Interval 4.2 to 22.0
|
|
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
Interval 0.3 to 4.5
|
3.1 percentage of participants
Interval 0.6 to 15.2
|
8.6 percentage of participants
Interval 2.1 to 28.7
|
7.4 percentage of participants
Interval 1.5 to 30.0
|
|
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
Interval 2.2 to 11.2
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
2.1 percentage of participants
Interval 0.4 to 10.3
|
|
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
Interval 0.7 to 10.0
|
1.4 percentage of participants
Interval 0.4 to 5.1
|
15.5 percentage of participants
Interval 2.9 to 52.8
|
1.0 percentage of participants
Interval 0.1 to 8.8
|
|
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
Interval 0.1 to 3.6
|
3.4 percentage of participants
Interval 1.0 to 11.2
|
4.4 percentage of participants
Interval 1.3 to 13.8
|
4.4 percentage of participants
Interval 0.6 to 26.4
|
|
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
Interval 0.5 to 4.7
|
5.3 percentage of participants
Interval 2.1 to 13.1
|
5.7 percentage of participants
Interval 1.7 to 17.6
|
2.5 percentage of participants
Interval 0.8 to 7.8
|
|
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
Interval 0.8 to 6.4
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
5.0 percentage of participants
Interval 1.0 to 21.2
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
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
Interval 0.3 to 4.0
|
1.2 percentage of participants
Interval 0.3 to 4.6
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
2.1 percentage of participants
Interval 0.4 to 9.9
|
|
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
Interval 0.9 to 7.9
|
4.4 percentage of participants
Interval 0.7 to 22.2
|
0.7 percentage of participants
Interval 0.1 to 5.0
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
|
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
Interval 0.4 to 5.1
|
1.2 percentage of participants
Interval 0.3 to 4.6
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0.8 percentage of participants
Interval 0.1 to 6.2
|
|
Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country
Other
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
1.1 percentage of participants
Interval 0.1 to 9.5
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=662 Participants
|
> 10 Years
n=140 Participants
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 71.5 to 86.1
|
78.6 percentage of participants
Interval 58.2 to 90.6
|
—
|
—
|
|
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
Interval 58.4 to 83.3
|
33.3 percentage of participants
Interval 12.8 to 63.0
|
—
|
—
|
|
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
Interval 59.6 to 78.4
|
65.7 percentage of participants
Interval 50.8 to 78.1
|
—
|
—
|
|
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
Interval 39.9 to 60.5
|
74.0 percentage of participants
Interval 61.8 to 83.3
|
—
|
—
|
|
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
Interval 26.2 to 50.6
|
40.3 percentage of participants
Interval 29.1 to 52.6
|
—
|
—
|
|
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
Interval 13.3 to 27.5
|
25.2 percentage of participants
Interval 12.7 to 43.8
|
—
|
—
|
|
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
Interval 5.9 to 16.4
|
24.0 percentage of participants
Interval 11.9 to 42.4
|
—
|
—
|
|
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
Interval 5.5 to 17.5
|
18.8 percentage of participants
Interval 5.8 to 46.5
|
—
|
—
|
|
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
Interval 4.5 to 13.4
|
16.1 percentage of participants
Interval 8.4 to 28.9
|
—
|
—
|
|
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
Interval 5.4 to 14.7
|
8.2 percentage of participants
Interval 3.8 to 16.9
|
—
|
—
|
|
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
Interval 3.0 to 8.0
|
17.9 percentage of participants
Interval 7.2 to 37.9
|
—
|
—
|
|
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
Interval 2.3 to 8.9
|
8.6 percentage of participants
Interval 3.9 to 17.9
|
—
|
—
|
|
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
Interval 3.0 to 7.4
|
4.2 percentage of participants
Interval 1.1 to 14.4
|
—
|
—
|
|
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
Interval 2.1 to 10.2
|
4.2 percentage of participants
Interval 1.3 to 12.6
|
—
|
—
|
|
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
Interval 1.6 to 5.2
|
5.5 percentage of participants
Interval 1.8 to 15.6
|
—
|
—
|
|
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
Interval 1.9 to 5.9
|
4.7 percentage of participants
Interval 2.1 to 10.5
|
—
|
—
|
|
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
Interval 0.9 to 3.6
|
5.9 percentage of participants
Interval 2.0 to 16.3
|
—
|
—
|
|
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
Interval 1.2 to 4.2
|
3.0 percentage of participants
Interval 1.0 to 8.9
|
—
|
—
|
|
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
Interval 1.1 to 3.9
|
3.8 percentage of participants
Interval 1.1 to 12.6
|
—
|
—
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
—
|
—
|
|
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
Interval 0.1 to 1.4
|
1.0 percentage of participants
Interval 0.1 to 6.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=257 Participants
|
> 10 Years
n=687 Participants
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 1.4 to 10.3
|
3.6 percentage of participants
Interval 1.7 to 7.4
|
—
|
—
|
|
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
Interval 3.0 to 12.5
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
—
|
—
|
|
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
Interval 1.6 to 7.4
|
3.1 percentage of participants
Interval 1.8 to 5.3
|
—
|
—
|
|
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
Interval 60.4 to 87.5
|
76.8 percentage of participants
Interval 69.7 to 82.7
|
—
|
—
|
|
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
Interval 35.9 to 79.2
|
65.2 percentage of participants
Interval 50.5 to 77.5
|
—
|
—
|
|
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
Interval 42.9 to 71.1
|
71.1 percentage of participants
Interval 62.0 to 78.8
|
—
|
—
|
|
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
Interval 38.5 to 70.8
|
50.2 percentage of participants
Interval 41.7 to 58.8
|
—
|
—
|
|
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
Interval 18.0 to 42.6
|
40.2 percentage of participants
Interval 30.9 to 50.3
|
—
|
—
|
|
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
Interval 8.7 to 24.3
|
18.6 percentage of participants
Interval 12.8 to 26.0
|
—
|
—
|
|
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
Interval 8.6 to 29.6
|
12.5 percentage of participants
Interval 7.6 to 20.0
|
—
|
—
|
|
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
Interval 3.4 to 17.1
|
9.5 percentage of participants
Interval 5.2 to 16.8
|
—
|
—
|
|
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
Interval 4.9 to 19.8
|
8.5 percentage of participants
Interval 5.1 to 13.7
|
—
|
—
|
|
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
Interval 2.4 to 11.2
|
8.3 percentage of participants
Interval 5.3 to 12.7
|
—
|
—
|
|
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
Interval 2.1 to 8.8
|
7.6 percentage of participants
Interval 4.7 to 12.1
|
—
|
—
|
|
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
Interval 1.6 to 9.7
|
5.4 percentage of participants
Interval 3.1 to 9.1
|
—
|
—
|
|
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
Interval 1.5 to 7.6
|
4.0 percentage of participants
Interval 2.3 to 6.7
|
—
|
—
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
2.6 percentage of participants
Interval 1.3 to 5.1
|
—
|
—
|
|
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
Interval 0.6 to 5.0
|
2.4 percentage of participants
Interval 1.4 to 4.2
|
—
|
—
|
|
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
Interval 0.5 to 4.7
|
2.0 percentage of participants
Interval 1.0 to 3.9
|
—
|
—
|
|
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
Interval 0.1 to 2.9
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
—
|
—
|
|
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
Interval 0.1 to 2.8
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=302 Participants
|
> 10 Years
n=281 Participants
|
Romania
n=197 Participants
|
France
n=164 Participants
|
|---|---|---|---|---|
|
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
Interval 65.5 to 87.0
|
73.4 percentage of participants
Interval 56.3 to 85.5
|
90.6 percentage of participants
Interval 80.8 to 95.7
|
62.4 percentage of participants
Interval 39.8 to 80.7
|
|
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
Interval 38.6 to 88.0
|
65.2 percentage of participants
Interval 46.5 to 80.1
|
82.3 percentage of participants
Interval 57.1 to 94.2
|
41.8 percentage of participants
Interval 10.1 to 82.2
|
|
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
Interval 58.2 to 82.2
|
67.3 percentage of participants
Interval 52.9 to 79.0
|
63.5 percentage of participants
Interval 42.5 to 80.3
|
62.0 percentage of participants
Interval 39.4 to 80.4
|
|
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
Interval 27.7 to 56.0
|
58.4 percentage of participants
Interval 41.3 to 73.7
|
52.6 percentage of participants
Interval 36.9 to 67.8
|
67.3 percentage of participants
Interval 50.3 to 80.7
|
|
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
Interval 18.8 to 42.6
|
39.1 percentage of participants
Interval 26.0 to 54.0
|
35.2 percentage of participants
Interval 17.8 to 57.7
|
53.3 percentage of participants
Interval 23.3 to 81.1
|
|
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
Interval 10.2 to 32.2
|
16.1 percentage of participants
Interval 8.0 to 29.7
|
13.5 percentage of participants
Interval 5.7 to 28.6
|
29.9 percentage of participants
Interval 15.5 to 49.6
|
|
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
Interval 12.4 to 48.0
|
13.4 percentage of participants
Interval 7.9 to 21.9
|
4.8 percentage of participants
Interval 1.6 to 13.2
|
7.8 percentage of participants
Interval 3.2 to 17.5
|
|
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
Interval 4.5 to 32.4
|
7.0 percentage of participants
Interval 2.6 to 17.6
|
8.8 percentage of participants
Interval 3.2 to 21.7
|
8.1 percentage of participants
Interval 2.1 to 26.7
|
|
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
Interval 2.0 to 14.3
|
11.5 percentage of participants
Interval 6.3 to 20.2
|
11.9 percentage of participants
Interval 4.5 to 27.7
|
4.0 percentage of participants
Interval 1.0 to 14.2
|
|
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
Interval 2.4 to 16.8
|
11.6 percentage of participants
Interval 7.3 to 18.0
|
6.1 percentage of participants
Interval 2.5 to 14.5
|
2.5 percentage of participants
Interval 0.6 to 9.2
|
|
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
Interval 3.2 to 16.2
|
7.9 percentage of participants
Interval 3.5 to 16.8
|
5.0 percentage of participants
Interval 2.0 to 11.8
|
6.1 percentage of participants
Interval 1.4 to 23.4
|
|
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
Interval 2.0 to 12.5
|
4.6 percentage of participants
Interval 1.9 to 10.5
|
5.2 percentage of participants
Interval 1.6 to 15.6
|
3.0 percentage of participants
Interval 0.6 to 14.2
|
|
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
Interval 1.2 to 6.1
|
5.2 percentage of participants
Interval 2.7 to 9.6
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
9.7 percentage of participants
Interval 3.5 to 24.1
|
|
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
Interval 0.4 to 7.7
|
9.0 percentage of participants
Interval 3.6 to 20.6
|
2.1 percentage of participants
Interval 0.4 to 11.6
|
1.7 percentage of participants
Interval 0.4 to 8.0
|
|
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
Interval 1.4 to 7.6
|
3.2 percentage of participants
Interval 1.2 to 8.3
|
2.9 percentage of participants
Interval 0.8 to 10.8
|
1.6 percentage of participants
Interval 0.3 to 9.6
|
|
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
Interval 1.3 to 6.5
|
3.8 percentage of participants
Interval 1.6 to 8.8
|
3.0 percentage of participants
Interval 1.2 to 7.2
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
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
Interval 1.0 to 8.2
|
1.9 percentage of participants
Interval 0.6 to 5.6
|
2.3 percentage of participants
Interval 0.7 to 7.0
|
1.3 percentage of participants
Interval 0.3 to 5.1
|
|
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
Interval 0.6 to 5.2
|
2.3 percentage of participants
Interval 0.9 to 6.1
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
3.4 percentage of participants
Interval 1.1 to 9.8
|
|
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
Interval 0.2 to 2.6
|
1.3 percentage of participants
Interval 0.4 to 4.5
|
2.8 percentage of participants
Interval 0.8 to 9.5
|
3.5 percentage of participants
Interval 0.8 to 14.5
|
|
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
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
1.7 percentage of participants
Interval 0.6 to 4.8
|
1.4 percentage of participants
Interval 0.4 to 4.6
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
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
Interval 0.2 to 3.8
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0.5 percentage of participants
Interval 0.1 to 3.6
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=395 Participants
|
> 10 Years
n=248 Participants
|
Romania
n=182 Participants
|
France
n=119 Participants
|
|---|---|---|---|---|
|
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
Interval 73.9 to 87.2
|
64.5 percentage of participants
Interval 51.4 to 75.8
|
78.5 percentage of participants
Interval 64.1 to 88.2
|
62.6 percentage of participants
Interval 47.2 to 75.8
|
|
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
Interval 62.3 to 85.1
|
59.7 percentage of participants
Interval 39.5 to 77.0
|
45.4 percentage of participants
Interval 25.1 to 67.4
|
59.8 percentage of participants
Interval 35.7 to 79.9
|
|
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
Interval 57.1 to 78.6
|
66.6 percentage of participants
Interval 56.4 to 75.4
|
60.5 percentage of participants
Interval 46.9 to 72.6
|
62.7 percentage of participants
Interval 48.2 to 75.2
|
|
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
Interval 28.9 to 50.2
|
56.5 percentage of participants
Interval 44.1 to 68.1
|
69.5 percentage of participants
Interval 57.7 to 79.2
|
45.1 percentage of participants
Interval 30.7 to 60.4
|
|
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
Interval 17.3 to 36.9
|
49.5 percentage of participants
Interval 34.3 to 64.7
|
42.1 percentage of participants
Interval 30.0 to 55.2
|
44.0 percentage of participants
Interval 28.3 to 60.9
|
|
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
Interval 11.3 to 22.8
|
24.2 percentage of participants
Interval 15.4 to 35.9
|
29.1 percentage of participants
Interval 18.7 to 42.3
|
9.7 percentage of participants
Interval 4.0 to 21.5
|
|
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
Interval 5.8 to 17.9
|
16.1 percentage of participants
Interval 7.8 to 30.1
|
16.7 percentage of participants
Interval 8.4 to 30.4
|
14.5 percentage of participants
Interval 6.2 to 30.3
|
|
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
Interval 4.5 to 17.3
|
7.2 percentage of participants
Interval 3.5 to 14.1
|
18.1 percentage of participants
Interval 7.5 to 37.7
|
13.1 percentage of participants
Interval 6.7 to 24.0
|
|
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
Interval 4.1 to 14.0
|
12.7 percentage of participants
Interval 6.3 to 23.7
|
10.3 percentage of participants
Interval 5.1 to 19.9
|
10.4 percentage of participants
Interval 3.6 to 26.6
|
|
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
Interval 4.1 to 13.9
|
8.9 percentage of participants
Interval 4.7 to 16.4
|
8.2 percentage of participants
Interval 4.2 to 15.4
|
5.8 percentage of participants
Interval 2.3 to 13.8
|
|
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
Interval 1.9 to 7.9
|
4.1 percentage of participants
Interval 1.9 to 8.4
|
15.0 percentage of participants
Interval 7.1 to 29.1
|
7.9 percentage of participants
Interval 4.1 to 14.6
|
|
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
Interval 2.5 to 10.1
|
4.3 percentage of participants
Interval 1.7 to 10.5
|
7.2 percentage of participants
Interval 3.3 to 15.3
|
5.0 percentage of participants
Interval 1.7 to 13.7
|
|
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
Interval 2.9 to 8.5
|
2.7 percentage of participants
Interval 1.2 to 6.0
|
5.4 percentage of participants
Interval 2.1 to 13.1
|
5.2 percentage of participants
Interval 2.1 to 12.4
|
|
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
Interval 2.1 to 11.2
|
6.9 percentage of participants
Interval 2.6 to 16.6
|
5.7 percentage of participants
Interval 2.3 to 13.4
|
7.4 percentage of participants
Interval 2.6 to 18.9
|
|
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
Interval 1.2 to 5.9
|
3.3 percentage of participants
Interval 1.6 to 6.8
|
4.5 percentage of participants
Interval 1.8 to 11.0
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
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
Interval 1.6 to 6.1
|
2.6 percentage of participants
Interval 1.1 to 6.1
|
4.1 percentage of participants
Interval 1.9 to 8.4
|
3.9 percentage of participants
Interval 1.2 to 11.7
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
4.2 percentage of participants
Interval 2.0 to 8.5
|
4.9 percentage of participants
Interval 1.9 to 12.0
|
1.8 percentage of participants
Interval 0.4 to 7.7
|
|
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
Interval 1.3 to 5.3
|
0.8 percentage of participants
Interval 0.2 to 3.3
|
3.5 percentage of participants
Interval 1.5 to 8.2
|
2.6 percentage of participants
Interval 0.8 to 8.0
|
|
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
Interval 1.1 to 4.8
|
3.2 percentage of participants
Interval 1.3 to 7.4
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
2.9 percentage of participants
Interval 0.9 to 9.2
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
2.1 percentage of participants
Interval 0.8 to 5.6
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
1.8 percentage of participants
Interval 0.4 to 7.3
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
0.7 percentage of participants
Interval 0.1 to 4.5
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
SECONDARY outcome
Timeframe: Assessed at Baseline, prior to participant enrolment.Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=110 Investigators
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 80.6 to 93.5
|
—
|
—
|
—
|
|
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
Interval 73.2 to 88.6
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Guidelines
|
74.7 percentage of investigators
Interval 62.8 to 83.8
|
—
|
—
|
—
|
|
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
Interval 61.3 to 79.7
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Age
|
68.6 percentage of investigators
Interval 58.3 to 77.3
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Prior chemotherapy
|
67.4 percentage of investigators
Interval 57.6 to 75.8
|
—
|
—
|
—
|
|
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
Interval 53.7 to 74.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Comorbidities
|
64.4 percentage of investigators
Interval 53.8 to 73.7
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Tumor stage
|
64.3 percentage of investigators
Interval 53.6 to 73.8
|
—
|
—
|
—
|
|
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
Interval 52.7 to 72.7
|
—
|
—
|
—
|
|
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
Interval 44.4 to 69.4
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Tumor type
|
56.5 percentage of investigators
Interval 45.1 to 67.2
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Treatment intent
|
55.0 percentage of investigators
Interval 44.1 to 65.5
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Nutritional status
|
53.6 percentage of investigators
Interval 41.8 to 65.0
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Medications taken
|
49.4 percentage of investigators
Interval 37.8 to 61.2
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Current infection
|
44.8 percentage of investigators
Interval 34.0 to 56.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Open wounds
|
42.4 percentage of investigators
Interval 29.8 to 56.1
|
—
|
—
|
—
|
|
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
Interval 31.5 to 51.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Concurrent radiotherapy
|
39.7 percentage of investigators
Interval 27.6 to 53.1
|
—
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty
Female gender
|
32.4 percentage of investigators
Interval 21.1 to 46.0
|
—
|
—
|
—
|
|
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
Interval 20.5 to 40.8
|
—
|
—
|
—
|
|
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
Interval 2.2 to 12.3
|
—
|
—
|
—
|
|
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
Interval 0.9 to 8.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at Baseline, prior to participant enrolment.Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=48 Investigators
|
> 10 Years
n=117 Investigators
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 75.6 to 96.0
|
87.4 percentage of investigators
Interval 79.3 to 92.7
|
—
|
—
|
|
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
Interval 74.5 to 96.1
|
79.6 percentage of investigators
Interval 70.9 to 86.2
|
—
|
—
|
|
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
Interval 57.0 to 84.7
|
67.3 percentage of investigators
Interval 56.1 to 76.8
|
—
|
—
|
|
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
Interval 54.8 to 83.8
|
76.1 percentage of investigators
Interval 67.3 to 83.2
|
—
|
—
|
|
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
Interval 52.8 to 81.4
|
74.9 percentage of investigators
Interval 64.3 to 83.2
|
—
|
—
|
|
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
Interval 52.3 to 81.7
|
71.1 percentage of investigators
Interval 61.7 to 78.9
|
—
|
—
|
|
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
Interval 37.4 to 71.2
|
68.1 percentage of investigators
Interval 57.4 to 77.1
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
Comorbidities
|
52.1 percentage of investigators
Interval 36.8 to 67.0
|
67.0 percentage of investigators
Interval 57.0 to 75.7
|
—
|
—
|
|
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
Interval 43.4 to 76.0
|
61.5 percentage of investigators
Interval 51.3 to 70.8
|
—
|
—
|
|
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
Interval 47.3 to 79.3
|
63.8 percentage of investigators
Interval 53.9 to 72.6
|
—
|
—
|
|
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
Interval 41.5 to 73.9
|
62.7 percentage of investigators
Interval 50.9 to 73.2
|
—
|
—
|
|
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
Interval 44.2 to 75.2
|
63.4 percentage of investigators
Interval 52.5 to 73.0
|
—
|
—
|
|
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
Interval 33.0 to 63.2
|
52.2 percentage of investigators
Interval 41.0 to 63.3
|
—
|
—
|
|
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
Interval 28.1 to 66.4
|
49.3 percentage of investigators
Interval 39.7 to 58.9
|
—
|
—
|
|
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
Interval 26.7 to 65.3
|
48.8 percentage of investigators
Interval 38.2 to 59.5
|
—
|
—
|
|
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
Interval 24.7 to 56.7
|
47.3 percentage of investigators
Interval 37.5 to 57.3
|
—
|
—
|
|
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
Interval 16.7 to 48.1
|
40.5 percentage of investigators
Interval 29.9 to 52.0
|
—
|
—
|
|
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
Interval 20.5 to 49.2
|
43.5 percentage of investigators
Interval 34.4 to 53.1
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
Concurrent radiotherapy
|
44.0 percentage of investigators
Interval 27.8 to 61.6
|
41.4 percentage of investigators
Interval 31.3 to 52.3
|
—
|
—
|
|
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
Interval 11.9 to 39.5
|
24.5 percentage of investigators
Interval 16.3 to 35.1
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology
Planned relative dose intensity
|
27.1 percentage of investigators
Interval 15.6 to 42.8
|
25.8 percentage of investigators
Interval 17.8 to 35.8
|
—
|
—
|
|
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
Interval 1.1 to 19.0
|
3.8 percentage of investigators
Interval 1.4 to 9.6
|
—
|
—
|
|
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
Interval 0.2 to 15.9
|
2.6 percentage of investigators
Interval 0.8 to 7.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at Baseline, prior to participant enrolment.Population: Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=57 Investigators
|
> 10 Years
n=46 Investigators
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 75.6 to 97.2
|
87.0 percentage of investigators
Interval 72.9 to 94.3
|
—
|
—
|
|
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
Interval 73.3 to 94.7
|
78.3 percentage of investigators
Interval 61.1 to 89.3
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Guidelines
|
73.1 percentage of investigators
Interval 54.1 to 86.2
|
62.9 percentage of investigators
Interval 45.4 to 77.6
|
—
|
—
|
|
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
Interval 64.8 to 92.9
|
79.4 percentage of investigators
Interval 63.0 to 89.7
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Age
|
72.5 percentage of investigators
Interval 53.5 to 85.7
|
77.2 percentage of investigators
Interval 55.9 to 90.0
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Prior chemotherapy
|
75.1 percentage of investigators
Interval 57.3 to 87.1
|
72.0 percentage of investigators
Interval 53.0 to 85.4
|
—
|
—
|
|
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
Interval 42.3 to 72.9
|
74.1 percentage of investigators
Interval 57.4 to 85.9
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Comorbidities
|
68.4 percentage of investigators
Interval 54.7 to 79.5
|
62.0 percentage of investigators
Interval 41.1 to 79.3
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Tumor stage
|
58.6 percentage of investigators
Interval 38.1 to 76.5
|
64.5 percentage of investigators
Interval 47.3 to 78.6
|
—
|
—
|
|
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
Interval 57.9 to 88.8
|
61.5 percentage of investigators
Interval 41.2 to 78.5
|
—
|
—
|
|
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
Interval 58.7 to 90.2
|
63.0 percentage of investigators
Interval 44.0 to 78.6
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Tumor type
|
65.3 percentage of investigators
Interval 44.8 to 81.4
|
60.9 percentage of investigators
Interval 45.4 to 74.4
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Treatment intent
|
49.6 percentage of investigators
Interval 30.9 to 68.4
|
47.8 percentage of investigators
Interval 33.2 to 62.8
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Nutritional status
|
46.7 percentage of investigators
Interval 30.9 to 63.1
|
47.0 percentage of investigators
Interval 26.7 to 68.2
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Medications taken
|
51.5 percentage of investigators
Interval 31.1 to 71.3
|
50.8 percentage of investigators
Interval 34.7 to 66.7
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Current infection
|
40.7 percentage of investigators
Interval 26.0 to 57.3
|
55.6 percentage of investigators
Interval 37.9 to 71.9
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Open wounds
|
44.6 percentage of investigators
Interval 29.5 to 60.9
|
39.0 percentage of investigators
Interval 20.8 to 60.9
|
—
|
—
|
|
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
Interval 19.6 to 49.0
|
39.0 percentage of investigators
Interval 23.7 to 56.9
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Concurrent radiotherapy
|
45.9 percentage of investigators
Interval 29.1 to 63.8
|
34.2 percentage of investigators
Interval 18.0 to 55.2
|
—
|
—
|
|
Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type
Female gender
|
19.2 percentage of investigators
Interval 9.5 to 35.0
|
10.2 percentage of investigators
Interval 3.1 to 28.4
|
—
|
—
|
|
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
Interval 11.2 to 37.8
|
23.1 percentage of investigators
Interval 10.7 to 43.0
|
—
|
—
|
|
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
Interval 0.8 to 14.6
|
2.6 percentage of investigators
Interval 0.3 to 17.4
|
—
|
—
|
|
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
Interval 0.8 to 14.1
|
2.2 percentage of investigators
Interval 0.3 to 15.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; analysis only includes subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=205 Participants
|
> 10 Years
n=173 Participants
|
Romania
n=141 Participants
|
France
n=126 Participants
|
|---|---|---|---|---|
|
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
Interval 49.6 to 95.1
|
96.3 percentage of participants
Interval 80.7 to 99.4
|
98.2 percentage of participants
Interval 90.4 to 99.7
|
88.3 percentage of participants
Interval 59.0 to 97.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Tumor type
|
67.8 percentage of participants
Interval 28.1 to 91.9
|
61.4 percentage of participants
Interval 18.3 to 91.8
|
95.3 percentage of participants
Interval 82.6 to 98.9
|
67.9 percentage of participants
Interval 44.2 to 85.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Guidelines
|
85.3 percentage of participants
Interval 40.9 to 98.0
|
44.7 percentage of participants
Interval 21.4 to 70.6
|
91.0 percentage of participants
Interval 62.9 to 98.4
|
62.7 percentage of participants
Interval 24.1 to 89.9
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Tumor stage
|
47.3 percentage of participants
Interval 14.3 to 82.8
|
39.5 percentage of participants
Interval 17.9 to 66.0
|
69.4 percentage of participants
Interval 45.6 to 86.0
|
24.3 percentage of participants
Interval 11.4 to 44.3
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Age
|
50.1 percentage of participants
Interval 27.8 to 72.4
|
45.1 percentage of participants
Interval 24.7 to 67.3
|
33.0 percentage of participants
Interval 19.6 to 50.0
|
13.5 percentage of participants
Interval 5.2 to 30.8
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Treatment intent
|
15.8 percentage of participants
Interval 6.5 to 33.7
|
24.7 percentage of participants
Interval 12.2 to 43.5
|
52.0 percentage of participants
Interval 33.0 to 70.4
|
16.9 percentage of participants
Interval 3.9 to 50.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
ECOG/Karnofsky performance status
|
57.4 percentage of participants
Interval 29.8 to 81.1
|
29.3 percentage of participants
Interval 15.2 to 48.9
|
23.4 percentage of participants
Interval 8.0 to 51.9
|
19.4 percentage of participants
Interval 10.6 to 32.9
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Female gender
|
28.9 percentage of participants
Interval 15.0 to 48.3
|
4.1 percentage of participants
Interval 1.1 to 13.7
|
38.0 percentage of participants
Interval 18.3 to 62.6
|
8.7 percentage of participants
Interval 2.8 to 24.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Comorbidities
|
18.3 percentage of participants
Interval 11.7 to 27.5
|
18.2 percentage of participants
Interval 11.7 to 27.1
|
29.9 percentage of participants
Interval 14.5 to 51.9
|
6.4 percentage of participants
Interval 2.0 to 18.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Baseline laboratory values
|
18.5 percentage of participants
Interval 10.1 to 31.4
|
7.9 percentage of participants
Interval 2.3 to 23.3
|
27.7 percentage of participants
Interval 11.1 to 54.1
|
7.4 percentage of participants
Interval 2.4 to 20.6
|
|
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
Interval 1.1 to 16.7
|
19.2 percentage of participants
Interval 6.4 to 45.1
|
11.6 percentage of participants
Interval 2.9 to 36.7
|
26.8 percentage of participants
Interval 15.0 to 43.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Prior chemotherapy
|
14.1 percentage of participants
Interval 8.2 to 23.4
|
12.7 percentage of participants
Interval 7.1 to 21.7
|
28.8 percentage of participants
Interval 15.0 to 48.2
|
10.7 percentage of participants
Interval 5.4 to 20.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Nutritional status
|
9.0 percentage of participants
Interval 4.3 to 18.0
|
2.6 percentage of participants
Interval 0.5 to 11.6
|
12.6 percentage of participants
Interval 4.9 to 28.7
|
10.7 percentage of participants
Interval 4.9 to 21.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Planned relative dose intensity
|
4.3 percentage of participants
Interval 1.4 to 12.5
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
12.0 percentage of participants
Interval 1.4 to 57.1
|
3.5 percentage of participants
Interval 0.9 to 12.4
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Medications taken
|
1.9 percentage of participants
Interval 0.6 to 5.8
|
4.2 percentage of participants
Interval 1.7 to 10.0
|
5.0 percentage of participants
Interval 1.8 to 13.0
|
4.2 percentage of participants
Interval 1.5 to 11.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
History of prior FN
|
4.4 percentage of participants
Interval 1.2 to 15.2
|
2.9 percentage of participants
Interval 1.2 to 6.8
|
7.3 percentage of participants
Interval 3.2 to 15.9
|
4.0 percentage of participants
Interval 1.2 to 13.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Documented bone marrow involvement
|
1.0 percentage of participants
Interval 0.2 to 3.8
|
8.0 percentage of participants
Interval 2.1 to 26.3
|
2.6 percentage of participants
Interval 0.6 to 10.5
|
2.1 percentage of participants
Interval 0.5 to 8.7
|
|
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
Interval 2.5 to 10.6
|
3.6 percentage of participants
Interval 1.2 to 10.2
|
3.1 percentage of participants
Interval 1.0 to 9.3
|
1.6 percentage of participants
Interval 0.4 to 6.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Current infection
|
2.9 percentage of participants
Interval 1.2 to 6.7
|
4.0 percentage of participants
Interval 1.9 to 8.5
|
3.1 percentage of participants
Interval 0.6 to 15.0
|
1.0 percentage of participants
Interval 0.1 to 7.4
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Concurrent radiotherapy
|
2.3 percentage of participants
Interval 0.9 to 5.9
|
5.7 percentage of participants
Interval 2.2 to 13.6
|
0.7 percentage of participants
Interval 0.1 to 5.4
|
3.5 percentage of participants
Interval 1.0 to 11.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Open wounds
|
1.7 percentage of participants
Interval 0.5 to 5.4
|
0.7 percentage of participants
Interval 0.1 to 4.3
|
1.7 percentage of participants
Interval 0.4 to 6.5
|
0.8 percentage of participants
Interval 0.1 to 6.3
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Other patient related
|
0.5 percentage of participants
Interval 0.1 to 3.6
|
1.9 percentage of participants
Interval 0.4 to 9.0
|
2.5 percentage of participants
Interval 0.8 to 7.8
|
1.2 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country
Other disease/treatment related
|
2.3 percentage of participants
Interval 0.8 to 6.5
|
0.6 percentage of participants
Interval 0.1 to 4.2
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=662 Participants
|
> 10 Years
n=140 Participants
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 87.5 to 96.3
|
93.6 percentage of participants
Interval 84.4 to 97.5
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Tumor type
|
72.6 percentage of participants
Interval 59.0 to 83.0
|
81.4 percentage of participants
Interval 59.4 to 92.9
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Guidelines
|
71.9 percentage of participants
Interval 58.0 to 82.6
|
27.5 percentage of participants
Interval 11.0 to 53.7
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Tumor stage
|
49.0 percentage of participants
Interval 37.8 to 60.3
|
42.3 percentage of participants
Interval 26.3 to 60.2
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Age
|
40.9 percentage of participants
Interval 32.4 to 50.1
|
55.5 percentage of participants
Interval 42.2 to 68.0
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Treatment intent
|
30.4 percentage of participants
Interval 22.5 to 39.7
|
39.0 percentage of participants
Interval 23.7 to 56.8
|
—
|
—
|
|
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
Interval 21.1 to 41.1
|
28.8 percentage of participants
Interval 18.8 to 41.6
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Female gender
|
22.2 percentage of participants
Interval 14.6 to 32.3
|
13.6 percentage of participants
Interval 8.0 to 22.1
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Comorbidities
|
13.8 percentage of participants
Interval 10.2 to 18.3
|
27.2 percentage of participants
Interval 17.2 to 40.2
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Baseline laboratory values
|
15.1 percentage of participants
Interval 10.5 to 21.3
|
24.7 percentage of participants
Interval 14.2 to 39.5
|
—
|
—
|
|
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
Interval 10.4 to 27.5
|
10.0 percentage of participants
Interval 4.5 to 20.8
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Prior chemotherapy
|
15.7 percentage of participants
Interval 11.3 to 21.3
|
14.4 percentage of participants
Interval 9.2 to 21.8
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Nutritional status
|
7.3 percentage of participants
Interval 4.7 to 11.1
|
13.2 percentage of participants
Interval 6.7 to 24.5
|
—
|
—
|
|
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
Interval 4.0 to 14.6
|
9.4 percentage of participants
Interval 3.1 to 24.9
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Medications taken
|
4.0 percentage of participants
Interval 2.6 to 6.3
|
11.9 percentage of participants
Interval 5.6 to 23.4
|
—
|
—
|
|
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
Interval 2.1 to 6.1
|
5.7 percentage of participants
Interval 2.5 to 12.6
|
—
|
—
|
|
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
Interval 1.2 to 3.7
|
20.8 percentage of participants
Interval 12.2 to 33.1
|
—
|
—
|
|
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
Interval 3.0 to 6.5
|
2.9 percentage of participants
Interval 1.1 to 7.4
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Current infection
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
9.1 percentage of participants
Interval 4.3 to 18.3
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Concurrent radiotherapy
|
2.3 percentage of participants
Interval 1.4 to 4.0
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Open wounds
|
2.4 percentage of participants
Interval 1.3 to 4.4
|
2.7 percentage of participants
Interval 0.8 to 8.5
|
—
|
—
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty
Other patient related
|
1.3 percentage of participants
Interval 0.6 to 2.9
|
4.4 percentage of participants
Interval 1.6 to 11.7
|
—
|
—
|
|
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
Interval 0.5 to 2.6
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=257 Participants
|
> 10 Years
n=687 Participants
|
Romania
|
France
|
|---|---|---|---|---|
|
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
Interval 80.2 to 96.6
|
92.6 percentage of participants
Interval 87.5 to 95.7
|
—
|
—
|
|
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
Interval 41.0 to 75.0
|
76.6 percentage of participants
Interval 65.0 to 85.3
|
—
|
—
|
|
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
Interval 32.8 to 76.5
|
60.1 percentage of participants
Interval 45.9 to 72.8
|
—
|
—
|
|
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
Interval 22.6 to 49.6
|
45.9 percentage of participants
Interval 35.3 to 56.8
|
—
|
—
|
|
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
Interval 24.1 to 48.9
|
41.5 percentage of participants
Interval 33.3 to 50.2
|
—
|
—
|
|
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
Interval 17.7 to 38.3
|
32.3 percentage of participants
Interval 23.8 to 42.2
|
—
|
—
|
|
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
Interval 14.1 to 36.3
|
31.1 percentage of participants
Interval 23.8 to 39.6
|
—
|
—
|
|
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
Interval 7.6 to 20.0
|
21.1 percentage of participants
Interval 14.1 to 30.2
|
—
|
—
|
|
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
Interval 9.9 to 21.4
|
16.2 percentage of participants
Interval 12.4 to 20.8
|
—
|
—
|
|
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
Interval 7.0 to 21.7
|
15.5 percentage of participants
Interval 11.0 to 21.3
|
—
|
—
|
|
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
Interval 8.2 to 28.3
|
15.1 percentage of participants
Interval 9.7 to 22.7
|
—
|
—
|
|
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
Not applicable due to lack of convergence in the statistical model.
|
15.8 percentage of participants
Interval 11.9 to 20.6
|
—
|
—
|
|
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
Interval 2.5 to 11.0
|
9.2 percentage of participants
Interval 6.5 to 12.9
|
—
|
—
|
|
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
Interval 2.2 to 11.7
|
7.7 percentage of participants
Interval 4.3 to 13.6
|
—
|
—
|
|
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
Interval 3.0 to 9.5
|
5.0 percentage of participants
Interval 3.1 to 7.9
|
—
|
—
|
|
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
Interval 0.8 to 5.4
|
5.1 percentage of participants
Interval 3.3 to 7.9
|
—
|
—
|
|
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
Interval 1.5 to 6.7
|
4.8 percentage of participants
Interval 2.8 to 8.2
|
—
|
—
|
|
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
Interval 2.1 to 7.1
|
4.1 percentage of participants
Interval 2.8 to 6.2
|
—
|
—
|
|
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
Interval 0.7 to 4.7
|
4.5 percentage of participants
Interval 2.8 to 7.1
|
—
|
—
|
|
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
Interval 1.8 to 8.0
|
2.1 percentage of participants
Interval 1.2 to 3.7
|
—
|
—
|
|
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
Interval 0.2 to 3.3
|
2.7 percentage of participants
Interval 1.5 to 4.8
|
—
|
—
|
|
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
Interval 1.1 to 6.6
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
—
|
—
|
|
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
Interval 0.5 to 4.5
|
0.5 percentage of participants
Interval 0.2 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=302 Participants
|
> 10 Years
n=281 Participants
|
Romania
n=197 Participants
|
France
n=164 Participants
|
|---|---|---|---|---|
|
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
Interval 1.4 to 6.9
|
2.8 percentage of participants
Interval 1.4 to 5.6
|
5.2 percentage of participants
Interval 2.6 to 10.0
|
4.4 percentage of participants
Interval 1.9 to 9.9
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Current infection
|
4.9 percentage of participants
Interval 2.1 to 10.8
|
2.9 percentage of participants
Interval 1.2 to 6.8
|
3.3 percentage of participants
Interval 1.1 to 9.3
|
2.9 percentage of participants
Interval 1.1 to 7.7
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Concurrent radiotherapy
|
1.4 percentage of participants
Interval 0.5 to 4.3
|
2.1 percentage of participants
Interval 0.8 to 5.4
|
3.1 percentage of participants
Interval 1.3 to 7.3
|
2.2 percentage of participants
Interval 0.9 to 6.4
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Open wounds
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
1.8 percentage of participants
Interval 0.6 to 5.4
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
3.0 percentage of participants
Interval 1.1 to 7.8
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Other patient related
|
3.6 percentage of participants
Interval 1.4 to 9.1
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
2.4 percentage of participants
Interval 0.9 to 6.6
|
1.2 percentage of participants
Interval 0.3 to 5.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Other disease/treatment related
|
0 percentage of participants
Not applicable since the statistical model was not applied to calculate confidence limits for outcomes with no variation in response.
|
1.3 percentage of participants
Interval 0.5 to 3.8
|
0.6 percentage of participants
Interval 0.1 to 4.8
|
1.7 percentage of participants
Interval 0.5 to 5.9
|
|
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
Interval 87.7 to 98.4
|
92.7 percentage of participants
Interval 83.1 to 97.0
|
91.9 percentage of participants
Interval 76.1 to 97.6
|
86.1 percentage of participants
Interval 68.3 to 94.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Tumor type
|
66.2 percentage of participants
Interval 44.8 to 82.5
|
81.6 percentage of participants
Interval 60.1 to 92.9
|
68.7 percentage of participants
Interval 42.0 to 86.9
|
74.4 percentage of participants
Interval 38.9 to 93.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Guidelines
|
51.5 percentage of participants
Interval 27.6 to 74.8
|
64.0 percentage of participants
Interval 46.5 to 78.5
|
74.8 percentage of participants
Interval 46.8 to 90.9
|
54.6 percentage of participants
Interval 12.0 to 91.4
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Tumor stage
|
37.3 percentage of participants
Interval 21.7 to 56.0
|
51.4 percentage of participants
Interval 38.7 to 63.9
|
36.9 percentage of participants
Interval 20.4 to 57.2
|
44.8 percentage of participants
Interval 16.3 to 77.3
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Age
|
33.5 percentage of participants
Interval 20.1 to 50.2
|
37.8 percentage of participants
Interval 25.6 to 51.9
|
45.8 percentage of participants
Interval 31.5 to 60.9
|
50.3 percentage of participants
Interval 29.9 to 70.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Treatment intent
|
32.0 percentage of participants
Interval 19.0 to 48.4
|
33.7 percentage of participants
Interval 21.1 to 49.0
|
33.1 percentage of participants
Interval 19.9 to 49.5
|
17.2 percentage of participants
Interval 8.0 to 33.1
|
|
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
Interval 12.9 to 31.2
|
31.7 percentage of participants
Interval 19.9 to 46.4
|
29.3 percentage of participants
Interval 15.2 to 49.1
|
42.1 percentage of participants
Interval 21.5 to 65.9
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Female gender
|
14.9 percentage of participants
Interval 7.4 to 27.9
|
15.8 percentage of participants
Interval 8.2 to 28.4
|
22.6 percentage of participants
Interval 9.7 to 44.4
|
25.4 percentage of participants
Interval 12.1 to 45.7
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Comorbidities
|
14.3 percentage of participants
Interval 8.6 to 22.9
|
13.9 percentage of participants
Interval 9.3 to 20.1
|
17.8 percentage of participants
Interval 9.8 to 30.1
|
17.3 percentage of participants
Interval 10.6 to 27.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Baseline laboratory values
|
20.5 percentage of participants
Interval 10.5 to 36.2
|
12.5 percentage of participants
Interval 7.4 to 20.4
|
10.5 percentage of participants
Interval 4.4 to 23.0
|
22.1 percentage of participants
Interval 12.9 to 35.2
|
|
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
Interval 4.4 to 19.0
|
15.4 percentage of participants
Interval 7.6 to 28.6
|
37.6 percentage of participants
Interval 22.2 to 55.9
|
4.8 percentage of participants
Interval 1.5 to 14.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Prior chemotherapy
|
15.9 percentage of participants
Interval 9.5 to 25.3
|
13.0 percentage of participants
Interval 9.2 to 18.0
|
12.8 percentage of participants
Interval 7.0 to 22.4
|
18.5 percentage of participants
Interval 6.5 to 42.4
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Nutritional status
|
8.3 percentage of participants
Interval 4.2 to 15.8
|
11.2 percentage of participants
Interval 6.2 to 19.4
|
5.4 percentage of participants
Interval 2.4 to 11.6
|
5.9 percentage of participants
Interval 2.6 to 12.8
|
|
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
Interval 3.9 to 25.1
|
6.3 percentage of participants
Interval 2.4 to 15.5
|
4.1 percentage of participants
Interval 1.0 to 15.4
|
7.7 percentage of participants
Interval 1.9 to 26.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
Medications taken
|
6.2 percentage of participants
Interval 3.2 to 11.5
|
7.3 percentage of participants
Interval 3.5 to 14.6
|
2.9 percentage of participants
Interval 1.2 to 7.0
|
3.2 percentage of participants
Interval 0.9 to 10.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type
History of prior FN
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
3.0 percentage of participants
Interval 1.3 to 6.5
|
5.6 percentage of participants
Interval 2.7 to 11.3
|
3.9 percentage of participants
Interval 0.9 to 16.0
|
|
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
Interval 2.9 to 13.8
|
5.0 percentage of participants
Interval 2.3 to 10.7
|
3.6 percentage of participants
Interval 1.2 to 10.5
|
0.6 percentage of participants
Interval 0.1 to 4.4
|
SECONDARY outcome
Timeframe: At enrolment, prior to chemotherapy initiation.Population: Primary analysis set; analysis only included subgroups with at least 100 participants.
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=395 Participants
|
> 10 Years
n=248 Participants
|
Romania
n=182 Participants
|
France
n=119 Participants
|
|---|---|---|---|---|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Treatment intent
|
34.0 percentage of participants
Interval 23.9 to 45.7
|
25.2 percentage of participants
Interval 16.4 to 36.7
|
35.1 percentage of participants
Interval 23.4 to 48.9
|
22.2 percentage of participants
Interval 11.8 to 37.9
|
|
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
Interval 13.8 to 30.8
|
40.7 percentage of participants
Interval 27.8 to 55.0
|
32.6 percentage of participants
Interval 24.0 to 42.5
|
37.7 percentage of participants
Interval 24.1 to 53.6
|
|
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
Interval 13.7 to 31.8
|
16.2 percentage of participants
Interval 8.0 to 29.8
|
14.4 percentage of participants
Interval 7.1 to 27.0
|
22.6 percentage of participants
Interval 12.8 to 36.7
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Prior chemotherapy
|
12.4 percentage of participants
Interval 7.6 to 19.5
|
17.0 percentage of participants
Interval 11.7 to 24.2
|
14.3 percentage of participants
Interval 9.7 to 20.4
|
15.1 percentage of participants
Interval 9.4 to 23.4
|
|
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
Interval 3.4 to 13.9
|
5.7 percentage of participants
Interval 2.4 to 13.0
|
10.2 percentage of participants
Interval 4.4 to 21.9
|
10.8 percentage of participants
Interval 6.0 to 18.8
|
|
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
Interval 0.7 to 3.3
|
2.0 percentage of participants
Interval 0.8 to 4.8
|
19.4 percentage of participants
Interval 11.8 to 30.3
|
1.7 percentage of participants
Interval 0.4 to 6.6
|
|
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
Interval 2.3 to 6.6
|
5.9 percentage of participants
Interval 3.2 to 10.7
|
2.2 percentage of participants
Interval 0.8 to 5.8
|
3.4 percentage of participants
Interval 1.2 to 9.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Current infection
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
3.6 percentage of participants
Interval 1.8 to 6.9
|
8.8 percentage of participants
Interval 4.9 to 15.3
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Tumor stage
|
38.7 percentage of participants
Interval 28.3 to 50.2
|
57.7 percentage of participants
Interval 42.1 to 72.0
|
39.7 percentage of participants
Interval 26.6 to 54.4
|
64.7 percentage of participants
Interval 36.7 to 71.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Age
|
31.7 percentage of participants
Interval 23.5 to 41.3
|
42.3 percentage of participants
Interval 30.3 to 55.3
|
56.9 percentage of participants
Interval 45.9 to 67.2
|
33.5 percentage of participants
Interval 19.3 to 51.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Female gender
|
34.3 percentage of participants
Interval 22.5 to 48.5
|
8.2 percentage of participants
Interval 4.9 to 13.4
|
13.5 percentage of participants
Interval 8.2 to 21.3
|
6.8 percentage of participants
Interval 2.7 to 16.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Comorbidities
|
10.6 percentage of participants
Interval 7.0 to 15.9
|
18.0 percentage of participants
Interval 12.5 to 25.4
|
25.0 percentage of participants
Interval 17.0 to 35.1
|
17.8 percentage of participants
Interval 10.8 to 28.0
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Baseline laboratory values
|
13.2 percentage of participants
Interval 8.2 to 20.5
|
15.3 percentage of participants
Interval 9.4 to 23.9
|
21.9 percentage of participants
Interval 14.4 to 31.9
|
10.5 percentage of participants
Interval 4.5 to 22.5
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Nutritional status
|
4.3 percentage of participants
Interval 2.3 to 7.6
|
13.0 percentage of participants
Interval 7.8 to 20.8
|
14.3 percentage of participants
Interval 7.8 to 24.6
|
11.0 percentage of participants
Interval 5.9 to 19.8
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Guidelines
|
68.4 percentage of participants
Interval 55.5 to 78.9
|
62.7 percentage of participants
Interval 43.2 to 78.8
|
43.2 percentage of participants
Interval 23.2 to 65.7
|
56.3 percentage of participants
Interval 33.4 to 76.7
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Medications taken
|
3.9 percentage of participants
Interval 2.2 to 6.9
|
3.2 percentage of participants
Interval 1.6 to 6.3
|
11.1 percentage of participants
Interval 6.0 to 19.9
|
5.5 percentage of participants
Interval 2.2 to 13.1
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Concurrent radiotherapy
|
1.2 percentage of participants
Interval 0.4 to 3.0
|
2.9 percentage of participants
Interval 1.3 to 6.3
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
10.3 percentage of participants
Interval 5.4 to 19.0
|
|
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
Interval 2.2 to 7.0
|
3.2 percentage of participants
Interval 1.6 to 6.3
|
7.0 percentage of participants
Interval 3.3 to 14.2
|
2.7 percentage of participants
Interval 0.7 to 9.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Other patient related
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
2.6 percentage of participants
Interval 0.9 to 7.1
|
5.0 percentage of participants
Interval 2.0 to 11.5
|
2.6 percentage of participants
Interval 0.8 to 8.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Other disease/treatment related
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
1.1 percentage of participants
Interval 0.3 to 4.3
|
2.2 percentage of participants
Interval 0.6 to 7.6
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Open wounds
|
2.7 percentage of participants
Interval 1.3 to 5.4
|
1.4 percentage of participants
Interval 0.4 to 4.1
|
3.5 percentage of participants
Interval 1.4 to 8.3
|
NA percentage of participants
Not applicable due to lack of convergence in the statistical model.
|
|
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
Interval 88.9 to 96.6
|
85.8 percentage of participants
Interval 71.6 to 93.5
|
90.6 percentage of participants
Interval 81.8 to 95.4
|
80.5 percentage of participants
Interval 62.0 to 91.2
|
|
Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type
Tumor type
|
64.9 percentage of participants
Interval 49.4 to 77.8
|
75.9 percentage of participants
Interval 58.2 to 87.7
|
77.4 percentage of participants
Interval 59.6 to 88.8
|
64.7 percentage of participants
Interval 50.2 to 76.9
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Primary Analysis Set - Investigators
n=570 Participants
|
> 10 Years
|
Romania
|
France
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
Adverse Events
All Enrolled Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER