Clinical trial NCT01459653: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
Official title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia
Cancer
Breast Cancer
Ovarian Cancer
Lung Cancer
Prostate Cancer
Multiple Myeloma
Bladder Cancer
B-cell Lymphoma
Keywords: Febrile neutropenia
cancer
chemotherapy,
primary prophylaxis
secondary prophylaxis
filgrastim
granulocyte colony stimulating factor
observational study
noninterventional study
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 1496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar (EP2006) for primary or secondary prophylaxis for febrile neutropenia.

Brief summary: This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.


Eligibility criteria: Inclusion Criteria:

* Male or female adults (age \> / = 18 years)
* Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
* Planned to receive primary prophylaxis with filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle.
* Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) label.
* Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
* Informed written consent to participate in the study by patients or their legal guardian.

Exclusion Criteria:

* Patients with myeloid malignancies, with the exception of multiple myeloma.
* Sensitivity to filgrastim biosimilar or any other CSF.
* Hypersensitivity to E. coli-derived proteins.
* Radiotherapy to ≥ 20% of total body bone.
* Infection within two weeks of starting current line of chemotherapy.
* Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
* Patients with willfully negligent nonadherence to their cancer treatment.
* Use of any investigational agent in the 30 days prior to enrollment.
* Women of childbearing potential not using the contraception method(s) described above.
* Women who are breastfeeding.

Primary outcomes:
measure: Chemotherapy Toxicity (%FN Risk)
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Cancer Treatment Type - Ever Received During Study
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Fever and Infections Ever During the Study
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Clinical Events Ever During Study (Frequency Threshold: 5%)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Type of EP2006 Prophylaxis
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Type of EP2006 Prophylaxis by Gender
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Type of EP 2006 Prophylaxis by Age Group
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Type of EP 2006 Prophylaxis by Tumor Type
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Concomitant Antibiotic Prophylaxis
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Dose (All Cycles)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Dose (Enrollment Cycle)
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 1)
timeFrame: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 2)
timeFrame: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 3)
timeFrame: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 4)
timeFrame: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 5)
timeFrame: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose (Cycle 6)
timeFrame: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Dose by Patient Weight: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Dose by Tumor Type: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Dose by Chemotherapy Toxicity: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation: All Cycles
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation: Cycle 1
timeFrame: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation: Cycle 2
timeFrame: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation: Cycle 3
timeFrame: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation: Cycle 4
timeFrame: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation: Cycle 5
timeFrame: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation: Cycle 6
timeFrame: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation by Prophylaxis Type: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Treatment Duration in Any Cycle
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Treatment Duration in Cycle 1
timeFrame: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Treatment Duration in Cycle 2
timeFrame: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Treatment Duration in Cycle 3
timeFrame: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Treatment Duration in Cycle 4
timeFrame: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Treatment Duration in Cycle 5
timeFrame: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Treatment Duration in Cycle 6
timeFrame: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: EP2006 Duration by Tumor Type: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Duration by Prophylaxis Type: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Duration by Chemotherapy Toxicity: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Patient Risk Score (PRS) for All Patients
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation Relative to Guidelines by Cancer Type
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: GCSF Initiation Score (GIS)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: GCSF Persistence Score (GPS)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: GCSF Congruence Score (GCS)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Absolute Neutrophil Count (ANC) at EP2006 Initiation
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Absolute Neutrophil Count (ANC) Across All Cycles
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Patients With CIN/FN Episodes: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: CIN/FN Episodes: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes by Chemotherapy Risk: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes by Mean GIS: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes: Cycles Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes by Study Drug Duration: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Patients by Cause of Death
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Predictors of Absolute Neutrophil Count
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Day of Initiation: Cycle Distribution
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: EP2006 Cycles by Treatment Duration
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Incidence of Outcomes
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
Secondary outcomes:
measure: Cohort Identification
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Characteristics of Clusters: Hemoglobin Study Start
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Characteristics of Clusters: ECOG Performance Status
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Characteristics of Clusters: Cancer Stage
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Characteristics of Clusters: History of Antibiotic Use for CIN
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease
timeFrame: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
measure: Modeling Grade 4 CIN Episode: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling Grade 4 CIN Episode: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling FN Episode: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling FN Episode: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling CIN/FN-related Hospitalization: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling CIN/FN-related Hospitalization: Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Patient-level Predictors for All-cause Mortality
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
measure: Patient-level Predictor for Cancer-related Mortality
timeFrame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Sandoz Investigational Site
city: Kufstein
country: Austria
facility: Sandoz Investigational Site
city: Leoben
country: Austria
facility: Sandoz Investigational Site
city: Deurne
country: Belgium
facility: Sandoz Investigational Site
city: Tournai
country: Belgium
facility: Sandoz Investigational Site
city: Cheb
country: Czech Republic
facility: Sandoz Investigational Site
city: Chomutov
country: Czech Republic
facility: Sandoz Investigational Site
city: Praha
country: Czech Republic
facility: Sandoz Investigational Site
city: Teplice
country: Czech Republic
facility: Sandoz Investigational Site
city: Vítkovice
country: Czech Republic
facility: Sandoz Investigational Site
city: Agen
country: France
facility: Sandoz Investigational Site
city: Arras
country: France
facility: Sandoz Investigational Site
city: Avignon
country: France
facility: Sandoz Investigational Site
city: Bayonne
country: France
facility: Sandoz Investigational Site
city: Beauvais Cedex
country: France
facility: Sandoz Investigational Site
city: Blois
country: France
facility: Sandoz Investigational Site
city: Bois Guillaume Cedex
country: France
facility: Sandoz Investigational Site
city: Bordeaux Cedex
country: France
facility: Sandoz Investigational Site
city: Bordeaux
country: France
facility: Sandoz Investigational Site
city: Boulogne Sur Mer cedex
country: France
facility: Sandoz Investigational Site
city: Brest Cedex 2
country: France
facility: Sandoz Investigational Site
city: Colmar CEDEX
country: France
facility: Sandoz Investigational Site
city: Compiègne
country: France
facility: Sandoz Investigational Site
city: Gap Cedex
country: France
facility: Sandoz Investigational Site
city: Grenoble
country: France
facility: Sandoz Investigational Site
city: Libourne
country: France
facility: Sandoz Investigational Site
city: Lille Cedex
country: France
facility: Sandoz Investigational Site
city: Lyon 8
country: France
facility: Sandoz Investigational Site
city: Lyon Cedex 03
country: France
facility: Sandoz Investigational Site
city: Marseille
country: France
facility: Sandoz Investigational Site
city: Melun
country: France
facility: Sandoz Investigational Site
city: Montauban Cedex
country: France
facility: Sandoz Investigational Site
city: Montpellier Cedex 5
country: France
facility: Sandoz Investigational Site
city: Nancy
country: France
facility: Sandoz Investigational Site
city: Nîmes Cedex 9
country: France
facility: Sandoz Investigational Site
city: Orléans
country: France
facility: Sandoz Investigational Site
city: Paris Cedex 12
country: France
facility: Sandoz Investigational Site
city: Paris Cedex 15
country: France
facility: Sandoz Investigational Site
city: Perpignan
country: France
facility: Sandoz Investigational Site
city: Pierre Bénite
country: France
facility: Sandoz Investigational Site
city: Poitiers
country: France
facility: Sandoz Investigational Site
city: Reims Cedex
country: France
facility: Sandoz Investigational Site
city: Sainte-Foy-lès-Lyon
country: France
facility: Sandoz Investigational Site
city: Strasbourg Cedex
country: France
facility: Sandoz Investigational Site
city: Berlin
country: Germany
facility: Sandoz Investigational Site
city: Chemnitz
country: Germany
facility: Sandoz Investigational Site
city: Coburg
country: Germany
facility: Sandoz Investigational Site
city: Dortmund
country: Germany
facility: Sandoz Investigational Site
city: Erlangen
country: Germany
facility: Sandoz Investigational Site
city: Frankfurt
country: Germany
facility: Sandoz Investigational Site
city: Gera
country: Germany
facility: Sandoz Investigational Site
city: Hamburg
country: Germany
facility: Sandoz Investigational Site
city: Heinsberg
country: Germany
facility: Sandoz Investigational Site
city: Herne
country: Germany
facility: Sandoz Investigational Site
city: Langen
country: Germany
facility: Sandoz Investigational Site
city: Lehrte
country: Germany
facility: Sandoz Investigational Site
city: Leipzig
country: Germany
facility: Sandoz Investigational Site
city: Lübeck
country: Germany
facility: Sandoz Investigational Site
city: Munich
country: Germany
facility: Sandoz Investigational Site
city: Mülheim a. d. Ruhr
country: Germany
facility: Sandoz Investigational Site
city: Weiden
country: Germany
facility: Sandoz Investigational Site
city: Wismar
country: Germany
facility: Sandoz Investigational Site
city: Witten
country: Germany
facility: Sandoz Investigational Site
city: Wolfsburg
country: Germany
facility: Sandoz Investigational Site
city: Würselen
country: Germany
facility: Sandoz Investigational Site
city: Budapest
country: Hungary
facility: Sandoz Investigational Site
city: Gyor
country: Hungary
facility: Sandoz Investigational Site
city: Kecskemet
country: Hungary
facility: Sandoz Investigational Site
city: Pecs
country: Hungary
facility: Sandoz Investigational Site
city: Szekszard
country: Hungary
facility: Sandoz Investigational Site
city: Szombathely
country: Hungary
facility: Sandoz Investigational Site
city: Avezzano
country: Italy
facility: Sandoz Investigational Site
city: Avola
country: Italy
facility: Sandoz Investigational Site
city: Bari
country: Italy
facility: Sandoz Investigational Site
city: Campobasso
country: Italy
facility: Sandoz Investigational Site
city: Colleferro
country: Italy
facility: Sandoz Investigational Site
city: Cosenza
country: Italy
facility: Sandoz Investigational Site
city: Cuneo
country: Italy
facility: Sandoz Investigational Site
city: Frosinone
country: Italy
facility: Sandoz Investigational Site
city: Gaeta
country: Italy
facility: Sandoz Investigational Site
city: Genova
country: Italy
facility: Sandoz Investigational Site
city: La Spezia
country: Italy
facility: Sandoz Investigational Site
city: Matera
country: Italy
facility: Sandoz Investigational Site
city: Milano
country: Italy
facility: Sandoz Investigational Site
city: Monza
country: Italy
facility: Sandoz Investigational Site
city: Rieti
country: Italy
facility: Sandoz Investigational Site
city: Roma
country: Italy
facility: Sandoz Investigational Site
city: S. Giovanni Rotondo
country: Italy
facility: Sandoz Investigational Site
city: Sora
country: Italy
facility: Sandoz Investigational Site
city: Torino
country: Italy
facility: Sandoz Investigational Site
city: Białystok
country: Poland
facility: Sandoz Investigational Site
city: Brzozów
country: Poland
facility: Sandoz Investigational Site
city: Bydgoszcz
country: Poland
facility: Sandoz Investigational Site
city: Gdańsk
country: Poland
facility: Sandoz Investigational Site
city: Krakow
country: Poland
facility: Sandoz Investigational Site
city: Kraków
country: Poland
facility: Sandoz Investigational Site
city: Lublin
country: Poland
facility: Sandoz Investigational Site
city: Przemyśl
country: Poland
facility: Sandoz Investigational Site
city: Warszawa
country: Poland
facility: Sandoz Investigational Site
city: Wodzislaw Slaski
country: Poland
facility: Sandoz Investigational Site
city: Bucuresti
country: Romania
facility: Sandoz Investigational Site
city: Suceava
country: Romania
facility: Sandoz Investigational Site
city: Timisoara
country: Romania
facility: Sandoz Investigational Site
city: Tirgu Mures
country: Romania
facility: Sandoz Investigational Site
city: Alicante
country: Spain
facility: Sandoz Investigational Site
city: Barcelona
country: Spain
facility: Sandoz Investigational Site
city: Benidorm Alicante
country: Spain
facility: Sandoz Investigational Site
city: Bilbao
country: Spain
facility: Sandoz Investigational Site
city: Donostia-San Sebastián
country: Spain
facility: Sandoz Investigational Site
city: La Rioja
country: Spain
facility: Sandoz Investigational Site
city: Lorca
country: Spain
facility: Sandoz Investigational Site
city: Pamplona
country: Spain
facility: Sandoz Investigational Site
city: Valencia
country: Spain
facility: Sandoz Investigational Site
city: Vitoria-Gasteiz
country: Spain
facility: Sandoz Investigational Site
city: Genolier
country: Switzerland
facility: Sandoz Investigational Site
city: Zurich
country: Switzerland
facility: Sandoz Investigational Site
city: Cottingham
country: United Kingdom
facility: Sandoz Investigational Site
city: Liverpool
country: United Kingdom
facility: Sandoz Investigational Site
city: Rotherham
country: United Kingdom
facility: Sandoz Investigational Site
city: Scunthorpe
country: United Kingdom
facility: Sandoz Investigational Site
Study officials:
affiliation: Sandoz GmbH
name: Sandoz GmBH
role: STUDY_CHAIR
References: