Monitor-GCSF: Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT01459653

Collaborator

(none)

1,496

Enrollment

120

Locations

Duration (Months)

12.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Febrile Neutropenia Cancer Breast Cancer Ovarian Cancer Lung Cancer Prostate Cancer Multiple Myeloma Bladder Cancer B-cell Lymphoma

Study Design

Study Type:

Observational

Actual Enrollment :

1496 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Only 1 group Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

Outcome Measures

Primary Outcome Measures

Chemotherapy Toxicity (%FN Risk) [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.]
Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Cancer Treatment Type - Ever Received During Study [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]
Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Fever and Infections Ever During the Study [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]
Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Clinical Events Ever During Study (Frequency Threshold: 5%) [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]
Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
Type of EP2006 Prophylaxis [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Type of EP2006 Prophylaxis by Gender [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Type of EP 2006 Prophylaxis by Age Group [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Type of EP 2006 Prophylaxis by Tumor Type [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Concomitant Antibiotic Prophylaxis [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (All Cycles) [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Enrollment Cycle) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 1) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 2) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 3) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 4) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 5) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose (Cycle 6) [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose by Patient Weight: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose by Tumor Type: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor) [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Dose by Chemotherapy Toxicity: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: All Cycles [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 1 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 2 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 3 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 4 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 5 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation: Cycle 6 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation by Prophylaxis Type: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Any Cycle [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 1 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 2 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 3 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 4 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 5 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Treatment Duration in Cycle 6 [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.]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Duration by Tumor Type: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Duration by Prophylaxis Type: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
EP2006 Duration by Chemotherapy Toxicity: Cycle Level [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline [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.]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. * Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010). CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline [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.]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. * Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin
Patient Risk Score (PRS) for All Patients [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.]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type [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.]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer
Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient's chemotherapy toxicity (<10%, 10-20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated
EP2006 Day of Initiation Relative to Guidelines by Cancer Type [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. ^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines
GCSF Initiation Score (GIS) [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy) ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score
GCSF Persistence Score (GPS) [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0 ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor
GCSF Congruence Score (GCS) [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]
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence. CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);
Absolute Neutrophil Count (ANC) at EP2006 Initiation [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.]
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
Absolute Neutrophil Count (ANC) Across All Cycles [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]
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
Number of Patients With CIN/FN Episodes: Patient Level [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]
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance) A patient may fall into more than one or none of the categories displayed.
CIN/FN Episodes: Cycle Level [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]
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])
Incidence of Outcomes by Chemotherapy Risk: Patient Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of Outcomes by Mean GIS: Patient Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of Outcomes: Cycles Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). *Day of EP2006 initiation- Day 0 (during chemotherapy); **Day of EP2006 initiation- Days 1-3 (per guidelines)
Incidence of Outcomes by Study Drug Duration: Cycle Level [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;
Number of Patients by Cause of Death [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table shows number of patients that died in each group. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Predictors of Absolute Neutrophil Count [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]
Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used. Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin
Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count [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]
Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Mean and standard error estimated from ANCOVA
EP2006 Day of Initiation: Cycle Distribution [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery. Table presents number of cycles by day after chemotherapy.
EP2006 Cycles by Treatment Duration [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]
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery
Incidence of Outcomes [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]
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).

Secondary Outcome Measures

Cohort Identification [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
Characteristics of Clusters: Hemoglobin Study Start [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
Characteristics of Clusters: ECOG Performance Status [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982. FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group
Characteristics of Clusters: Cancer Stage [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
Characteristics of Clusters: History of Antibiotic Use for CIN [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia
Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease [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.]
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
Modeling Grade 4 CIN Episode: Cycle Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are added as statistical analyses appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score
Modeling Grade 4 CIN Episode: Patient Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are shown in the statistical appendices. H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia
Modeling FN Episode: Cycle Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group
Modeling FN Episode: Patient Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Modeling CIN/FN-related Hospitalization: Cycle Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
Modeling CIN/FN-related Hospitalization: Patient Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation
Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors) [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score.
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level [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]
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of
Patient-level Predictors for All-cause Mortality [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]
Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes. Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study
Patient-level Predictor for Cancer-related Mortality [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]
Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes. Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Sandoz Investigational Site	Innsbruck	Austria
2	Sandoz Investigational Site	Kufstein	Austria
3	Sandoz Investigational Site	Leoben	Austria
4	Sandoz Investigational Site	Deurne	Belgium
5	Sandoz Investigational Site	Tournai	Belgium
6	Sandoz Investigational Site	Cheb	Czech Republic
7	Sandoz Investigational Site	Chomutov	Czech Republic
8	Sandoz Investigational Site	Praha	Czech Republic
9	Sandoz Investigational Site	Teplice	Czech Republic
10	Sandoz Investigational Site	Vítkovice	Czech Republic
11	Sandoz Investigational Site	Agen	France
12	Sandoz Investigational Site	Arras	France
13	Sandoz Investigational Site	Avignon	France
14	Sandoz Investigational Site	Bayonne	France
15	Sandoz Investigational Site	Beauvais Cedex	France
16	Sandoz Investigational Site	Blois	France
17	Sandoz Investigational Site	Bois Guillaume Cedex	France
18	Sandoz Investigational Site	Bordeaux Cedex	France
19	Sandoz Investigational Site	Bordeaux	France
20	Sandoz Investigational Site	Boulogne Sur Mer cedex	France
21	Sandoz Investigational Site	Brest Cedex 2	France
22	Sandoz Investigational Site	Colmar CEDEX	France
23	Sandoz Investigational Site	Compiègne	France
24	Sandoz Investigational Site	Gap Cedex	France
25	Sandoz Investigational Site	Grenoble	France
26	Sandoz Investigational Site	Libourne	France
27	Sandoz Investigational Site	Lille Cedex	France
28	Sandoz Investigational Site	Lyon 8	France
29	Sandoz Investigational Site	Lyon Cedex 03	France
30	Sandoz Investigational Site	Marseille	France
31	Sandoz Investigational Site	Melun	France
32	Sandoz Investigational Site	Montauban Cedex	France
33	Sandoz Investigational Site	Montpellier Cedex 5	France
34	Sandoz Investigational Site	Nancy	France
35	Sandoz Investigational Site	Nîmes Cedex 9	France
36	Sandoz Investigational Site	Orléans	France
37	Sandoz Investigational Site	Paris Cedex 12	France
38	Sandoz Investigational Site	Paris Cedex 15	France
39	Sandoz Investigational Site	Perpignan	France
40	Sandoz Investigational Site	Pierre Bénite	France
41	Sandoz Investigational Site	Poitiers	France
42	Sandoz Investigational Site	Reims Cedex	France
43	Sandoz Investigational Site	Sainte-Foy-lès-Lyon	France
44	Sandoz Investigational Site	Strasbourg Cedex	France
45	Sandoz Investigational Site	Berlin	Germany
46	Sandoz Investigational Site	Chemnitz	Germany
47	Sandoz Investigational Site	Coburg	Germany
48	Sandoz Investigational Site	Dortmund	Germany
49	Sandoz Investigational Site	Erlangen	Germany
50	Sandoz Investigational Site	Frankfurt	Germany
51	Sandoz Investigational Site	Gera	Germany
52	Sandoz Investigational Site	Hamburg	Germany
53	Sandoz Investigational Site	Heinsberg	Germany
54	Sandoz Investigational Site	Herne	Germany
55	Sandoz Investigational Site	Langen	Germany
56	Sandoz Investigational Site	Lehrte	Germany
57	Sandoz Investigational Site	Leipzig	Germany
58	Sandoz Investigational Site	Lübeck	Germany
59	Sandoz Investigational Site	Munich	Germany
60	Sandoz Investigational Site	Mülheim a. d. Ruhr	Germany
61	Sandoz Investigational Site	Weiden	Germany
62	Sandoz Investigational Site	Wismar	Germany
63	Sandoz Investigational Site	Witten	Germany
64	Sandoz Investigational Site	Wolfsburg	Germany
65	Sandoz Investigational Site	Würselen	Germany
66	Sandoz Investigational Site	Budapest	Hungary
67	Sandoz Investigational Site	Gyor	Hungary
68	Sandoz Investigational Site	Kecskemet	Hungary
69	Sandoz Investigational Site	Pecs	Hungary
70	Sandoz Investigational Site	Szekszard	Hungary
71	Sandoz Investigational Site	Szombathely	Hungary
72	Sandoz Investigational Site	Avezzano	Italy
73	Sandoz Investigational Site	Avola	Italy
74	Sandoz Investigational Site	Bari	Italy
75	Sandoz Investigational Site	Campobasso	Italy
76	Sandoz Investigational Site	Colleferro	Italy
77	Sandoz Investigational Site	Cosenza	Italy
78	Sandoz Investigational Site	Cuneo	Italy
79	Sandoz Investigational Site	Frosinone	Italy
80	Sandoz Investigational Site	Gaeta	Italy
81	Sandoz Investigational Site	Genova	Italy
82	Sandoz Investigational Site	La Spezia	Italy
83	Sandoz Investigational Site	Matera	Italy
84	Sandoz Investigational Site	Milano	Italy
85	Sandoz Investigational Site	Monza	Italy
86	Sandoz Investigational Site	Rieti	Italy
87	Sandoz Investigational Site	Roma	Italy
88	Sandoz Investigational Site	S. Giovanni Rotondo	Italy
89	Sandoz Investigational Site	Sora	Italy
90	Sandoz Investigational Site	Torino	Italy
91	Sandoz Investigational Site	Białystok	Poland
92	Sandoz Investigational Site	Brzozów	Poland
93	Sandoz Investigational Site	Bydgoszcz	Poland
94	Sandoz Investigational Site	Gdańsk	Poland
95	Sandoz Investigational Site	Krakow	Poland
96	Sandoz Investigational Site	Kraków	Poland
97	Sandoz Investigational Site	Lublin	Poland
98	Sandoz Investigational Site	Przemyśl	Poland
99	Sandoz Investigational Site	Warszawa	Poland
100	Sandoz Investigational Site	Wodzislaw Slaski	Poland
101	Sandoz Investigational Site	Bucuresti	Romania
102	Sandoz Investigational Site	Suceava	Romania
103	Sandoz Investigational Site	Timisoara	Romania
104	Sandoz Investigational Site	Tirgu Mures	Romania
105	Sandoz Investigational Site	Alicante	Spain
106	Sandoz Investigational Site	Barcelona	Spain
107	Sandoz Investigational Site	Benidorm Alicante	Spain
108	Sandoz Investigational Site	Bilbao	Spain
109	Sandoz Investigational Site	Donostia-San Sebastián	Spain
110	Sandoz Investigational Site	La Rioja	Spain
111	Sandoz Investigational Site	Lorca	Spain
112	Sandoz Investigational Site	Pamplona	Spain
113	Sandoz Investigational Site	Valencia	Spain
114	Sandoz Investigational Site	Vitoria-Gasteiz	Spain
115	Sandoz Investigational Site	Genolier	Switzerland
116	Sandoz Investigational Site	Zurich	Switzerland
117	Sandoz Investigational Site	Cottingham	United Kingdom
118	Sandoz Investigational Site	Liverpool	United Kingdom
119	Sandoz Investigational Site	Rotherham	United Kingdom
120	Sandoz Investigational Site	Scunthorpe	United Kingdom

Sponsors and Collaborators

Sandoz

Investigators

Study Chair: Sandoz GmBH, Sandoz GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sandoz

ClinicalTrials.gov Identifier:

NCT01459653

Other Study ID Numbers:

EP06-502

First Posted:

Oct 25, 2011

Last Update Posted:

Jan 11, 2016

Last Verified:

Dec 1, 2015

Keywords provided by Sandoz

secondary prophylaxis

filgrastim

granulocyte colony stimulating factor

observational study

noninterventional study

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Period Title: Overall Study
STARTED	1496
COMPLETED	828
NOT COMPLETED	668

Baseline Characteristics

Arm/Group Title	EP2006, Evaluable Sample
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
Overall Participants	1447
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (11.8)
Sex: Female, Male (Count of Participants)
Female	886 61.2%
Male	561 38.8%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	1042 72%
African	7 0.5%
Asian	2 0.1%
Other	1 0.1%
Missing	395 27.3%
Region of Enrollment (participants) [Number]
France	395 27.3%
Hungary	143 9.9%
Czech Republic	50 3.5%
Spain	116 8%
Poland	286 19.8%
Belgium	3 0.2%
Romania	64 4.4%
Austria	27 1.9%
Germany	145 10%
United Kingdom	32 2.2%
Switzerland	11 0.8%
Italy	175 12.1%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	165.6 (8.5)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	72.1 (15.0)
Body-Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.3 (5.0)
Medical history (participants) [Number]
Bone pain	116 8%
Joint pain	78 5.4%
Muscle pain	31 2.1%
Headache	28 1.9%
Epistaxis	8 0.6%
GI bleeding	7 0.5%
Skin hemorrhage	1 0.1%
Comorbidities (participants) [Number]
Hypertension	458 31.7%
Anemia	138 9.5%
Diabetes Type II	122 8.4%
Coronary disease	93 6.4%
Allergies	90 6.2%
COPD	86 5.9%
History of repeated infections (participants) [Number]
History of any repeated infection	35 2.4%
Type of repeated infection (chronic)	8 0.6%
Type of repeated infection (recurrent, acute)	27 1.9%
1 infectious episode in past 3 months	15 1%
2 infectious episodes in past 3 months	7 0.5%
3 or more infectious episodes in past 3 months	3 0.2%
Cancer type (participants) [Number]
Breast	466 32.2%
Lung	345 23.8%
Lymphoma (DLBCL)	245 16.9%
Ovarian	140 9.7%
Prostate	102 7%
Multiple myeloma	85 5.9%
Bladder	64 4.4%
Cancer stage & type (participants) [Number]
Breast (stage III, n=466)	267 18.5%
Breast (stage IV, n=466)	194 13.4%
Lung (stage III, n=345)	101 7%
Lung (stage IV, n=345)	241 16.7%
Lymphoma (DLBCL) (stage III, n=245)	103 7.1%
Lymphoma (DLBCL) (stage IV, n=245)	135 9.3%
Ovarian (stage III, n=140)	63 4.4%
Ovarian (stage IV, n=140)	77 5.3%
Prostate (stage III, n=102)	7 0.5%
Prostate (stage IV, n=102)	95 6.6%
Multiple myeloma (stage III, n=85)	53 3.7%
Multiple myeloma (stage IV, n=85)	16 1.1%
Bladder (stage III, n=64)	16 1.1%
Bladder (stage IV, n=64)	48 3.3%
Overall, Stage III	610 42.2%
Overall, Stage IV	806 55.7%
Breast (unknown, n=466)	5 0.3%
Lung (unknown, n=345)	3 0.2%
Lymphoma (DLBCL) (unknown, n=245)	7 0.5%
Multiple myeloma (unknown, N=85)	16 1.1%
Overall, unknown	31 2.1%
Prior cancer treatments (participants) [Number]
None	518 35.8%
Surgery	472 32.6%
Chemotherapy	460 31.8%
Radiation therapy	274 18.9%
Hormonal therapy	198 13.7%
Targeted therapy	45 3.1%
Bone marrow transplant	12 0.8%
Other (including CAM)	25 1.7%
Prior Chemotherapy, Adjuvant	196 13.5%
Prior Chemotherapy, metastatic setting	206 14.2%
Cancer treatment (participants) [Number]
Chemotherapy cycle at study entry (1)	1046 72.3%
Chemotherapy cycle at study entry (2)	221 15.3%
Chemotherapy cycle at study entry (3)	93 6.4%
Chemotherapy cycle at study entry (4)	44 3%
Chemotherapy cycle at study entry (5)	26 1.8%
Chemotherapy cycle at study entry (6)	17 1.2%
History of prior CIN/FN and prior CIN/FN treatments (participants) [Number]
Prior CIN grade 4 episodes (any)	106 7.3%
Prior CIN grade 4 episodes (1)	79 5.5%
Prior CIN grade 4 episodes (2)	5 0.3%
Prior CIN grade 4 episodes (≥3)	15 1%
Prior CIN grade 4 episodes (missing)	7 0.5%
Prior FN	27 1.9%
Hospitalization for CIN/FN	33 2.3%
Any chemotherapy disturbance due to CIN/FN	48 3.3%
Prior treatments for CIN/FN (CSF therapy)	55 3.8%
Prior treatments for CIN/FN (antibiotics)	44 3%
Prior treatments for CIN/FN (antiviral)	0 0%
Prior treatments for CIN/FN (antifungal)	7 0.5%
Prior treatments for CIN/FN (corticosteroids)	5 0.3%
Prior treatments for CIN/FN (antipyretics)	12 0.8%
Treatment(s) for prior infections (participants) [Number]
Antibiotic	33 2.3%
Antifungal	2 0.1%
GCSF	2 0.1%
Antiviral	1 0.1%
ECOG score at enrollment (participants) [Number]
ECOG Score 0	553 38.2%
ECOG Score 1	652 45.1%
ECOG Score 2	121 8.4%
ECOG Score 3	26 1.8%
ECOG Score 4	1 0.1%
ECOG score Missing	94 6.5%
Cause(s) of prior repeated infections (participants) [Number]
Respiratory infections	15 1%
Neutropenia	11 0.8%
Cancer	8 0.6%
High use of antibiotics	3 0.2%
Urinary tract infections	3 0.2%
Immunosuppression	3 0.2%
Diabetes mellitus	2 0.1%
History of prior clinical events (participants) [Number]
Bone pain	116 8%
Muscle pain	31 2.1%
Joint pain	78 5.4%
Headache	28 1.9%
Cancer stage by tumor type (participants) [Number]
Solid tumor (n=1117), Stage III	454 31.4%
Solid tumor (n=1117), Stage IV	655 45.3%
Hematological tumor (n=330), Stage III	156 10.8%
Hematological tumor (n=330), Stage IV	151 10.4%
Solid tumor (n=1117), Stage unknown	8 0.6%
Hematological tumor (n=330), Stage unknown	23 1.6%

Outcome Measures

1. Primary Outcome

Title	Chemotherapy Toxicity (%FN Risk)
Description	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Time Frame	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.

Outcome Measure Data

Analysis Population Description
The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Low (<10%)	154 10.6%
Medium (10-20%)	650 44.9%
High (>20%)	640 44.2%
Missing	3 0.2%

2. Primary Outcome

Title	Cancer Treatment Type - Ever Received During Study
Description	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Time Frame	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

Outcome Measure Data

Analysis Population Description
The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Surgery	100 6.9%
Radiotherapy	102 7%
Hormonal therapy	85 5.9%
Targeted treatment	89 6.2%
Bone marrow transplant	31 2.1%
Other (e.g., CAM)	98 6.8%

3. Primary Outcome

Title	Fever and Infections Ever During the Study
Description	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Fever ever during study	76 5.3%
Infections ever during study	231 16%

4. Primary Outcome

Title	Clinical Events Ever During Study (Frequency Threshold: 5%)
Description	Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Bone pain	357 24.7%
Thrombocytopenia	230 15.9%
Serum LDH increase	222 15.3%
Muscle pain	210 14.5%
Joint pain	200 13.8%
Serum GGT increase	178 12.3%
Serum ALP increase	168 11.6%
Other neurological symptoms	102 7%
Headache	100 6.9%
Blood uric acid increase	88 6.1%

5. Primary Outcome

Title	Type of EP2006 Prophylaxis
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle. True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle.

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Primary (initiated in cycle1)	1046 72.3%
Secondary (initiated in cycle2 or later)	401 27.7%
Delayed primary	245 16.9%
True secondary	156 10.8%

6. Primary Outcome

Title	Type of EP2006 Prophylaxis by Gender
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by gender

Arm/Group Title	EP2006: Male	EP2006: Female
Arm/Group Description	Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	561	886
Primary (initiated in cycle1)	397 27.4%	649 NaN
Secondary (initiated in cycle2 or later)	164 11.3%	237 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3038
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.8840
	Confidence Interval	(2-Sided) 95% 0.6989 to 1.1182
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Type of EP 2006 Prophylaxis by Age Group
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by age

Arm/Group Title	EP2006: <65 Years	EP2006: >=65 Years
Arm/Group Description	Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	849	598
Primary (initiated in cycle1)	626 43.3%	420 NaN
Secondary, initiated in cycle2 or later	223 15.4%	178 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1432
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.1897
	Confidence Interval	(2-Sided) 95% 0.9428 to 1.5012
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	Type of EP 2006 Prophylaxis by Tumor Type
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by tumor type

Arm/Group Title	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1117	330
Primary (initiated in cycle1)	801 55.4%	245 NaN
Secondary (initiated in ≥cycle2)	316 21.8%	85 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6483
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.8794
	Confidence Interval	(2-Sided) 95% 0.5063 to 1.5276
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	Concomitant Antibiotic Prophylaxis
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Concomitant antibiotic prophylaxis	175 12.1%
No Concomitant antibiotic prophylaxis	1261 87.1%
Missing	11 0.8%

10. Primary Outcome

Title	EP2006 Dose (All Cycles)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
All cycles from patients in the evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	5986
30 MIU/day	3182
48 MIU/day	2756
Other	48

11. Primary Outcome

Title	EP2006 Dose (Enrollment Cycle)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at enrollment cycle with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1434
30 MIU/day	815 56.3%
48 MIU/day	610 42.2%
Other	9 0.6%

12. Primary Outcome

Title	EP2006 Dose (Cycle 1)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 1 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1036
30 MIU/day	593 41%
48 MIU/day	434 30%
Other	9 0.6%

13. Primary Outcome

Title	EP2006 Dose (Cycle 2)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 2 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1143
30 MIU/day	627 43.3%
48 MIU/day	507 35%
Other	9 0.6%

14. Primary Outcome

Title	EP2006 Dose (Cycle 3)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 3 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1125
30 MIU/day	597 41.3%
48 MIU/day	519 35.9%
Other	9 0.6%

15. Primary Outcome

Title	EP2006 Dose (Cycle 4)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 4 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1045
30 MIU/day	548 37.9%
48 MIU/day	490 33.9%
Other	7 0.5%

16. Primary Outcome

Title	EP2006 Dose (Cycle 5)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 5 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	862
30 MIU/day	431 29.8%
48 MIU/day	424 29.3%
Other	7 0.5%

17. Primary Outcome

Title	EP2006 Dose (Cycle 6)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of participants at cycle 6 with dose data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	775
30 MIU/day	386 26.7%
48 MIU/day	382 26.4%
Other	7 0.5%

18. Primary Outcome

Title	EP2006 Dose by Patient Weight: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
All cycles treated

Arm/Group Title	EP2006: <=65kg	EP2006: >65kg
Arm/Group Description	Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	568	857
Measure cycles	2272	3666
30 MIU/day	1501	1681
48 MIU/day	771	1985

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.2989
	Confidence Interval	(2-Sided) 95% 1.8113 to 2.9177
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Primary Outcome

Title	EP2006 Dose by Tumor Type: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1104	328
Measure cycles	4609	1329
30 MIU/day	2296	886
48 MIU/day	2313	443

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.4963
	Confidence Interval	(2-Sided) 95% 0.3730 to 0.6605
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Primary Outcome

Title	Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by tumor type

Arm/Group Title	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1117	330
≤65 kg	441 30.5%	135 NaN
>65 kg	676 46.7%	195 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7509
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.9451
	Confidence Interval	(2-Sided) 95% 0.6671 to 1.3391
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Primary Outcome

Title	EP2006 Dose by Chemotherapy Toxicity: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: Risk <10%	EP2006: Risk 10-20%	EP2006: Risk >20%
Arm/Group Description	Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	151	647	631
Measure cycles	546	2534	2843
30 MIU/day	357	1375	1441
48 MIU/day	189	1159	1402

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0067
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.2683
	Confidence Interval	(2-Sided) 95% 1.0680 to 1.5061
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Primary Outcome

Title	EP2006 Day of Initiation: All Cycles
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with day of initiation of study drug

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	5930
Mean (Standard Deviation) [days]	3.1 (3.0)

23. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 1
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 1

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1017
Measure cycles	1017
Mean (Standard Deviation) [days]	3.4 (3.2)

24. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 2
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 2

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1132
Measure cycles	1132
Mean (Standard Deviation) [days]	3.1 (3.0)

25. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 3
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 3

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1111
Measure cycles	1111
Mean (Standard Deviation) [days]	3.0 (2.9)

26. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 4
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 4

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1038
Measure cycles	1038
Mean (Standard Deviation) [days]	3.0 (2.9)

27. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 5
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 5

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	858
Measure cycles	858
Mean (Standard Deviation) [days]	2.9 (2.9)

28. Primary Outcome

Title	EP2006 Day of Initiation: Cycle 6
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with study drug initiation day at cycle 6

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	774
Measure cycles	774
Mean (Standard Deviation) [days]	3.0 (2.9)

29. Primary Outcome

Title	EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1103	320
Measure cycles	4614	1316
Mean (Standard Deviation) [days]	2.6 (2.7)	4.8 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4507

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.0628
	Confidence Interval	(2-Sided) 95% 0.6382 to 1.4874
	Parameter Dispersion	Type: Value:
	Estimation Comments

30. Primary Outcome

Title	EP2006 Day of Initiation by Prophylaxis Type: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: Primary Prophylaxis	EP2006: Secondary Prophylaxis
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.	Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
Measure Participants	1033	390
Measure cycles	4700	1230
Mean (Standard Deviation) [days]	3.2 (3.0)	2.6 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0103
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4507

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.2739
	Confidence Interval	(2-Sided) 95% -0.4832 to -0.0646
	Parameter Dispersion	Type: Value:
	Estimation Comments

31. Primary Outcome

Title	EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: <10% Risk	EP2006: 10-20% Risk	EP2006: >20% Risk
Arm/Group Description	Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	150	637	633
Measure cycles	542	2504	2869
Mean (Standard Deviation) [days]	2.3 (2.9)	3.0 (3.0)	3.3 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4495

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.3812
	Confidence Interval	(2-Sided) 95% 0.2330 to 0.5295
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Primary Outcome

Title	EP2006 Treatment Duration in Any Cycle
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
All cycles from patients in the evaluable sample with study drug duration

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1426
Measure cycles	5942
Mean (Standard Deviation) [days]	5.1 (2.3)

33. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 1
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 1

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1025
Measure cycles	1025
Mean (Standard Deviation) [days]	5.2 (2.2)

34. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 2
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 2

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1134
Measure cycles	1134
Mean (Standard Deviation) [days]	5.1 (2.3)

35. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 3
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 3

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1117
Measure cycles	1117
Mean (Standard Deviation) [days]	5.2 (2.3)

36. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 4
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 4

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1039
Measure cycles	1039
Mean (Standard Deviation) [days]	5.1 (2.3)

37. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 5
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 5

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	856
Measure cycles	856
Mean (Standard Deviation) [days]	5.1 (2.4)

38. Primary Outcome

Title	EP2006 Treatment Duration in Cycle 6
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Cycles of participants in evaluable sample with study drug duration in cycle 6

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	771
Measure cycles	771
Mean (Standard Deviation) [days]	5.0 (2.4)

39. Primary Outcome

Title	EP2006 Duration by Tumor Type: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by tumor type with data

Arm/Group Title	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1103	323
Measure cycles	4619	1323
Mean (Standard Deviation) [days]	5.14 (2.24)	5.03 (2.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0677
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4516

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.1031
	Confidence Interval	(2-Sided) 95% -0.0075 to 0.2136
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Primary Outcome

Title	EP2006 Duration by Prophylaxis Type: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: Primary Prophylaxis	EP2006: Secondary Prophylaxis
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
Measure Participants	1033	393
Measure cycles	4703	1239
Mean (Standard Deviation) [days]	5.1 (2.2)	5.2 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8968
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4516

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.0018
	Confidence Interval	(2-Sided) 95% -0.0259 to 0.0295
	Parameter Dispersion	Type: Value:
	Estimation Comments

41. Primary Outcome

Title	EP2006 Duration by Chemotherapy Toxicity: Cycle Level
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006: <10% Risk	EP2006: 10-20% Risk	EP2006: >20% Risk
Arm/Group Description	Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	150	638	635
Measure cycles	541	2513	2875
Mean (Standard Deviation) [days]	4.6 (2.4)	5.0 (2.2)	5.3 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	degrees of freedom: 4505

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.0741
	Confidence Interval	(2-Sided) 95% -0.0452 to 0.1029
	Parameter Dispersion	Type: Value:
	Estimation Comments

42. Primary Outcome

Title	Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. * Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010). CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Age >=65 years	41.3 2.9%
Advanced disease*	13.7 0.9%
History of FN	1.9 0.1%
No antibiotic prophylaxis	87.8 6.1%
Poor performance and/or nutritional status	13.1 0.9%
Female gender	61.2 4.2%
Hb < 12 g/dL	39.6 2.7%
Renal, CV, or liver disease	23.1 1.6%

43. Primary Outcome

Title	Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. * Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Patients with chemotherapy risk 10-20% in evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	650
Age >=65 years	44.6
Advanced disease*	20.8
History of FN	2.0
No antibiotic prophylaxis	91.3
Poor performance and/or nutritional status	13.3
Female gender	57.8
Hb < 12 g/dL	45.9
Renal, CV, or liver disease	26.9

44. Secondary Outcome

Title	Cohort Identification
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).

Arm/Group Title	EP2006 - Group 1
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
EP2006 - Group 1	1192 82.4%
EP2006 - Group 2	43 3%
Missing	212 14.7%

45. Secondary Outcome

Title	Characteristics of Clusters: Hemoglobin Study Start
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for hemoglobin at study start.

Arm/Group Title	EP2006 - Group 1	EP2006 - Group 2
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1175	43
Mean (Standard Deviation) [g/dL]	12.35 (1.80)	11.82 (1.86)

46. Primary Outcome

Title	Patient Risk Score (PRS) for All Patients
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Mean (Standard Deviation) [Scores on a scale]	2.9 (2.0)

47. Primary Outcome

Title	Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type

Arm/Group Title	EP2006 - All Patients	EP2006 - Solid Tumor	EP2006 - Hematological Tumor
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
Measure Participants	650	568	82
Mean (Standard Deviation) [Scores on a scale]	3.3 (2.0)	3.2 (1.9)	3.4 (2.4)

48. Primary Outcome

Title	Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006, >20% Chemo-associated FN Risk	EP2006, 10-20% Chemo-associated FN Risk	EP2006, <10% Chemo-associated FN Risk
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
Measure Participants	640	650	154
Primary prophylaxis: Correctly treated (%)	35.0 2.4%	17.3 NaN	0 NaN
Primary prophylaxis:Over-treated (%)	0 0%	13.0 NaN	6.9 NaN
Secondary prophylaxis: Correctly treated (%)	0 0%	3.1 NaN	1.2 NaN
Secondary prophylaxis: Under-treated (%)	9.3 0.6%	8.1 NaN	0 NaN
Secondary prophylaxis: Over-treated (%)	0 0%	3.5 NaN	2.6 NaN
Primary prophylaxis: Under-treated (%)	0 0%	0 NaN	0 NaN

49. Primary Outcome

Title	Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient's chemotherapy toxicity (<10%, 10-20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample: total and by tumor type

Arm/Group Title	EP2006: All Patients	EP2006: Solid Tumor	EP2006: Hematological Tumor
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1444	1115	329
Under-treated (%)	17.3	16.3	21.0
Correctly or Over-treated (%)	82.5	83.7	79.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2698
	Comments
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.7350
	Confidence Interval	(2-Sided) 95% 0.4255 to 1.2698
	Parameter Dispersion	Type: Value:
	Estimation Comments

50. Primary Outcome

Title	EP2006 Day of Initiation Relative to Guidelines by Cancer Type
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. ^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines
Time Frame	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

Outcome Measure Data

Analysis Population Description
Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.

Arm/Group Title	EP2006: EP2006 Initiation During Chemotherapy (Day 0)	EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)	EP2006: EP2006 Initiation Later (Day 4 or More)^
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
Measure Participants	234	851	473
Measure cycles	795	3320	1815
Breast	178	1410	624
Lung	305	691	225
Lymphoma (DLBCL)	23	386	671
Ovarian	109	332	119
Prostate	26	278	95
Multiple myeloma	32	167	37
Bladder	122	56	44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

51. Primary Outcome

Title	GCSF Initiation Score (GIS)
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy) ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score
Time Frame	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

Outcome Measure Data

Analysis Population Description
The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1423
GIS score 0 (%)	15.9 1.1%
GIS score 0.50 (%)	11.5 0.8%
GIS score 0.75 (%)	16.6 1.1%
GIS score 1.0 (%)	56.0 3.9%

52. Primary Outcome

Title	GCSF Persistence Score (GPS)
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0 ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor
Time Frame	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

Outcome Measure Data

Analysis Population Description
Patients in the evaluable sample with a GCSF persistence score (GPS).

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1295
GPS score 0	123 8.5%
GPS score 0.33	2 0.1%
GPS score 0.50	3 0.2%
GPS score 0.60	2 0.1%
GPS score 0.67	4 0.3%
GPS score 0.75	1 0.1%
GPS score 0.80	3 0.2%
GPS score 1	1157 80%

53. Primary Outcome

Title	GCSF Congruence Score (GCS)
Description	Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence. CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with GCSF congruence score by tumor type

Arm/Group Title	EP2006 - All Patients	EP2006 - Solid Tumor	EP2006 - Hematological Tumor
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1278	1015	263
Mean (Standard Deviation) [scores on a scale]	2.5 (0.6)	2.5 (0.6)	2.5 (0.5)

54. Primary Outcome

Title	Absolute Neutrophil Count (ANC) at EP2006 Initiation
Description	Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Number of patients in evaluable sample with initial ANC result

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1283
Mean (Standard Deviation) [Per mm^3]	4429.7 (4725.8)

55. Primary Outcome

Title	Absolute Neutrophil Count (ANC) Across All Cycles
Description	Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006 Cycles
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	7792
Mean (Standard Deviation) [Per mm^3]	4585.6 (3889.8)

56. Primary Outcome

Title	Number of Patients With CIN/FN Episodes: Patient Level
Description	Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance) A patient may fall into more than one or none of the categories displayed.
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
CIN any grade	504 34.8%
CIN grade 3/4	332 22.9%
CIN grade 4	191 13.2%
FN	86 5.9%
CIN/FN-related hospitalization	88 6.1%
CIN/FN-related chemotherapy disturbance	138 9.5%
Composite	323 22.3%

57. Primary Outcome

Title	CIN/FN Episodes: Cycle Level
Description	Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])
Time Frame	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

Outcome Measure Data

Analysis Population Description
Number of cycles in evaluable sample

Arm/Group Title	EP2006 Cycle Level
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	7570
CIN any grade (n=7557)	1083
CIN grade 3/4 (n=7541)	602
CIN grade 4 (n=7541)	294
FN (n=7532)	105
CIN/FN-RH (n=7531)	111
CIN/FN-RCD (n=6213)	174
Composite (n=7570)	507

58. Primary Outcome

Title	Incidence of Outcomes by Chemotherapy Risk: Patient Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by chemotherapy risk

Arm/Group Title	EP2006: Low (<10%) Risk	EP2006: Medium (10-20%) Risk	EP2006: High (>20%) Risk
Arm/Group Description	Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	154	650	640
CIN grade 4	7.8 0.5%	11.8 NaN	15.9 NaN
FN	3.9 0.3%	3.5 NaN	8.9 NaN
Composite^	16.9 1.2%	20.9 NaN	25.2 NaN

59. Primary Outcome

Title	Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by prophylaxis type

Arm/Group Title	EP2006: Primary Prophylaxis	EP2006: Secondary Prophylaxis
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
Measure Participants	1046	401
Number [Percentage of participants]	7.5 0.5%	15.0 NaN

60. Primary Outcome

Title	Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by prophylaxis decision (relative to guidelines)

Arm/Group Title	EP2006: Undertreated	EP2006: Correctly Treated	EP2006: Overtreated
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
Measure Participants	251	817	376
CIN grade 4	12.0 0.8%	16.8 NaN	6.4 NaN
FN	5.2 0.4%	8.0 NaN	2.1 NaN
CIN/FN-related hospitalization	8.0 0.6%	7.1 NaN	2.7 NaN
CIN/FN-related chemotherapy disturbance	14.7 1%	8.8 NaN	7.7 NaN
Composite^	24.7 1.7%	26.0 NaN	13.0 NaN

61. Primary Outcome

Title	Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by study drug dose

Arm/Group Title	EP2006: 30MIU/Day	EP2006: 48MIU/Day
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
Measure Participants	815	610
Number [percentage of participants]	11.3 0.8%	15.9 NaN

62. Primary Outcome

Title	Incidence of Outcomes by Mean GIS: Patient Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by mean GIS

Arm/Group Title	EP2006: Mean GIS 0-0.5	EP2006: Mean GIS 0.51-0.99	EP2006: Mean GIS 1
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
Measure Participants	390	308	725
CIN grade 4	17.7 1.2%	17.5 NaN	9.2 NaN
Composite^	26.9 1.9%	24.7 NaN	18.9 NaN

63. Primary Outcome

Title	Incidence of Outcomes: Cycles Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
CIN grade 4	3.9 0.3%
FN	1.4 0.1%
CIN/FN-related hospitalization	1.5 0.1%
CIN/FN-related chemotherapy disturbance	2.8 0.2%
Composite^	6.7 0.5%

64. Primary Outcome

Title	Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). Day of EP2006 initiation- Day 0 (during chemotherapy); *Day of EP2006 initiation- Days 1-3 (per guidelines)
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.

Arm/Group Title	EP2006: Day 0 (During Chemotherapy)	EP2006: Days 1-3 (Per Guidelines)	EP2006: Day 4 or Later
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
Measure Participants	234	851	473
CIN grade 4	3.1 0.2%	2.8 NaN	7.3 NaN
FN	1.0 0.1%	1.2 NaN	2.1 NaN
Composite^	5.8 0.4%	5.4 NaN	9.1 NaN

65. Primary Outcome

Title	Incidence of Outcomes by Study Drug Duration: Cycle Level
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.

Arm/Group Title	EP2006: 1-3 Days Duration	EP2006: 4-5 Days Duration	EP2006: >=6 Days Duration
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
Measure Participants	380	784	419
CIN grade 4	3.6 0.2%	3.9 NaN	5.5 NaN
FN	1.2 0.1%	1.2 NaN	2.2 NaN
CIN/FN-related chemotherapy disturbance	2.0 0.1%	2.1 NaN	4.7 NaN
Composite^	6.0 0.4%	5.8 NaN	9.3 NaN

66. Primary Outcome

Title	Number of Patients by Cause of Death
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Safety population, i.e. all patients who received at least one dose of study drug

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1496
All cause	61 4.2%
Cancer-related	41 2.8%
Non-cancer related	14 1%
Cause of death specified as "unknown"	4 0.3%
Cause of death not documented	2 0.1%

67. Primary Outcome

Title	Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table shows number of patients that died in each group. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by any/no grade 4 CIN/FN

Arm/Group Title	EP2006: Any Grade 4 CIN/FN	EP2006: No Grade 4 CIN/FN
Arm/Group Description	Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	221	1226
Number [participants]	10 0.7%	46 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5977
	Comments
	Method	Log Rank
	Comments

68. Primary Outcome

Title	Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by any or no CIN/FN related chemotherapy disturbance.

Arm/Group Title	EP2006: Any CIN/FN-related Chemotherapy Disturbance	EP2006: no CIN/FN-related Chemotherapy Disturbance
Arm/Group Description	Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	138	1309
Number [participants]	3 0.2%	53 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2435
	Comments
	Method	Log Rank
	Comments

69. Primary Outcome

Title	Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by any/no grade 4 CIN or FN with data

Arm/Group Title	EP2006: Any Grade 4 CIN/FN	EP2006: No Grade 4 CIN/FN
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
Measure Participants	221	1220
Number [participants]	6 0.4%	29 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7630
	Comments
	Method	Log Rank
	Comments

70. Primary Outcome

Title	Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data

Arm/Group Title	EP2006: Any CIN/FN-related Chemotherapy Disturbance	EP2006: No CIN/FN-related Chemotherapy Disturbance
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
Measure Participants	138	1303
Number [participants]	2 0.1%	33 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3830
	Comments
	Method	Log Rank
	Comments

71. Primary Outcome

Title	Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by prophylaxis type

Arm/Group Title	EP2006: Primary Prophylaxis	EP2006: Secondary Prophylaxis
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
Measure Participants	1046	401
Number [participants]	78 5.4%	60 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Log Rank
	Comments

72. Primary Outcome

Title	Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample by treatment decision with data

Arm/Group Title	EP2006: Undertreated	EP2006: Correctly Treated	EP2006: Over Treated
Arm/Group Description	Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	251	817	376
Number [participants]	37 2.6%	72 NaN	29 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006, EP2006: Female, EP2006: Risk >20%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0301
	Comments
	Method	Log Rank
	Comments

73. Primary Outcome

Title	Predictors of Absolute Neutrophil Count
Description	Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used. Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin
Time Frame	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

Outcome Measure Data

Analysis Population Description
Cycles for patients in evaluable sample with data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1185
Measure cycles	4333
Number [participants]	1185 81.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GCSF treatment decision (under vs correct) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0683
	Comments
	Method	Regression, Logistic
	Comments	degrees of freedom: 3181

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95% 0.84 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GCSF decision (Over vs correct) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0019
	Comments
	Method	Regression, Logistic
	Comments	degrees of freedom: 3181

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.82 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GCSF decision (Under vs over) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4469
	Comments
	Method	Regression, Logistic
	Comments	degrees of freedom: 3181

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 0.94 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Study drug dose (higher vs lower) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0079
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95% 1.03 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Tumor type (hematological vs solid) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.72 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Patient gender (female vs male) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95% 0.80 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG (per 1 point) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0235
	Comments
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 1.01 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Hb (per g/dL) as predictor for ANC
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95% 1.02 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

74. Primary Outcome

Title	Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count
Description	Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Mean and standard error estimated from ANCOVA
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1185
Measure cycles	4333
Number [participants]	1185 81.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Intra-class correlation coefficient
	Estimated Value	0.09
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments	The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Intra-class correlation coefficient
	Estimated Value	0.41
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Intra-class correlation coefficient
	Estimated Value	0.50
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

75. Secondary Outcome

Title	Characteristics of Clusters: ECOG Performance Status
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982. FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group
Time Frame	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.

Outcome Measure Data

Analysis Population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for ECOG performance status.

Arm/Group Title	EP2006 - Group 1	EP2006 - Group 2
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1145	39
Mean (Standard Deviation) [Scores on a scale]	0.75 (0.72)	0.87 (0.61)

76. Secondary Outcome

Title	Characteristics of Clusters: Cancer Stage
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for cancer stage.

Arm/Group Title	EP2006 - Group 1	EP2006 - Group 2
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1192	41
Cancer Stage III	511 35.3%	12 NaN
Cancer Stage IV	681 47.1%	29 NaN

77. Secondary Outcome

Title	Characteristics of Clusters: History of Antibiotic Use for CIN
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for history of antibiotic use for CIN.

Arm/Group Title	EP2006 - Group 1	EP2006 - Group 2
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1192	41
No history for antibiotic use for CIN	1190 82.2%	17 NaN
History for antibiotic use for CIN (Yes)	2 0.1%	24 NaN

78. Secondary Outcome

Title	Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease
Description	Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
Time Frame	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.

Outcome Measure Data

Analysis Population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for liver, renal and/or cardiovascular disease.

Arm/Group Title	EP2006 - Group 1	EP2006 - Group 2
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1192	41
No Liver, renal and/or cardiovascular disease	931 64.3%	19 NaN
Liver, renal and/or cardiovascular disease (Yes)	261 18%	22 NaN

79. Secondary Outcome

Title	Modeling Grade 4 CIN Episode: Cycle Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are added as statistical analyses appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score
Time Frame	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

Outcome Measure Data

Analysis Population Description
Number of cycles in evaluable sample with any grade 4 CIN data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1078
Measure cycles	5514
Number [cycles]	294

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.544
	Confidence Interval	(2-Sided) 95% 0.365 to 0.812
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.795
	Confidence Interval	(2-Sided) 95% 3.242 to 7.092
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.083
	Confidence Interval	(2-Sided) 95% 3.242 to 7.092
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.460
	Confidence Interval	(2-Sided) 95% 1.542 to 3.925
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.452
	Confidence Interval	(2-Sided) 95% 0.267 to 0.766
	Parameter Dispersion	Type: Value:
	Estimation Comments

80. Secondary Outcome

Title	Modeling Grade 4 CIN Episode: Patient Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are shown in the statistical appendices. H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1323
Number [participants]	191 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.925
	Confidence Interval	(2-Sided) 95% 1.592 to 5.374
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.572
	Confidence Interval	(2-Sided) 95% 1.331 to 4.969
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.328
	Confidence Interval	(2-Sided) 95% 0.193 to 0.557
	Parameter Dispersion	Type: Value:
	Estimation Comments

81. Secondary Outcome

Title	Modeling FN Episode: Cycle Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group
Time Frame	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

Outcome Measure Data

Analysis Population Description
Number of cycles of patients in evaluable sample with FN episode data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1273
Measure cycles	6362
Number [cycles]	105

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG score (per 1 point) as cycle-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.673
	Confidence Interval	(2-Sided) 95% 1.284 to 2.179
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.704
	Confidence Interval	(2-Sided) 95% 2.777 to 7.968
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	CIN1/4 in previous cycle as cycle-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.190
	Confidence Interval	(2-Sided) 95% 1.342 to 3.574
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of anaemia at enrollment as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.215
	Confidence Interval	(2-Sided) 95% 0.067 to 0.687
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. over-prophylacted as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.501
	Confidence Interval	(2-Sided) 95% 1.169 to 10.487
	Parameter Dispersion	Type: Value:
	Estimation Comments

82. Secondary Outcome

Title	Modeling FN Episode: Patient Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with FN episode data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1376
Number [participants]	86 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Patient age (per 1 year) as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.975
	Confidence Interval	(2-Sided) 95% 0.958 to 0.991
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG ≥2 during study as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.398
	Confidence Interval	(2-Sided) 95% 1.610 to 3.570
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.562
	Confidence Interval	(2-Sided) 95% 1.450 to 4.527
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.232
	Confidence Interval	(2-Sided) 95% 0.108 to 0.499
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. over-prophylacted as patient-level predictor for FN episode
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.261
	Confidence Interval	(2-Sided) 95% 1.315 to 8.084
	Parameter Dispersion	Type: Value:
	Estimation Comments

83. Secondary Outcome

Title	Modeling CIN/FN-related Hospitalization: Cycle Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1383
Measure cycles	6928
Number [cycles]	111

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.814
	Confidence Interval	(2-Sided) 95% 1.397 to 2.355
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.296
	Confidence Interval	(2-Sided) 95% 1.791 to 6.065
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.205
	Confidence Interval	(2-Sided) 95% 1.380 to 3.524
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.863
	Confidence Interval	(2-Sided) 95% 1.054 to 3.293
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.385
	Confidence Interval	(2-Sided) 95% 0.168 to 0.879
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.843
	Confidence Interval	(2-Sided) 95% 1.964 to 11.942
	Parameter Dispersion	Type: Value:
	Estimation Comments

84. Secondary Outcome

Title	Modeling CIN/FN-related Hospitalization: Patient Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with CIN/FN-related hospitalization data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1387
Number [participants]	88 6.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.473
	Confidence Interval	(2-Sided) 95% 1.550 to 3.946
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.382
	Confidence Interval	(2-Sided) 95% 0.210 to 0.695
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.108
	Confidence Interval	(2-Sided) 95% 1.560 to 6.192
	Parameter Dispersion	Type: Value:
	Estimation Comments

85. Secondary Outcome

Title	Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation
Time Frame	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

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1045
Measure cycles	3376
Number [cycles]	174

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.931
	Confidence Interval	(2-Sided) 95% 5.426 to 14.699
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.336
	Confidence Interval	(2-Sided) 95% 0.152 to 0.740
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.999
	Confidence Interval	(2-Sided) 95% 0.999 to 1.000
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.001
	Confidence Interval	(2-Sided) 95% 1.000 to 1.001
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.456
	Confidence Interval	(2-Sided) 95% 1.127 to 5.353
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.344
	Confidence Interval	(2-Sided) 95% 1.342 to 8.331
	Parameter Dispersion	Type: Value:
	Estimation Comments

86. Secondary Outcome

Title	Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with CIN/FN-related chemotherapy disturbance data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1334
Number [cycles]	138

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.965
	Confidence Interval	(2-Sided) 95% 1.218 to 3.172
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.594
	Confidence Interval	(2-Sided) 95% 1.469 to 4.581
	Parameter Dispersion	Type: Value:
	Estimation Comments

87. Secondary Outcome

Title	Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Cycles of patients from evaluable sample with composite outcome data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1529
Measure cycles	5193
Number [cycles]	507

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.590
	Confidence Interval	(2-Sided) 95% 0.424 to 0.821
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.644
	Confidence Interval	(2-Sided) 95% 0.489 to 0.859
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.579
	Confidence Interval	(2-Sided) 95% 0.398 to 0.842
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.369
	Confidence Interval	(2-Sided) 95% 1.140 to 1.643
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.499
	Confidence Interval	(2-Sided) 95% 2.456 to 4.985
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.064
	Confidence Interval	(2-Sided) 95% 3.096 to 5.336
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.545
	Confidence Interval	(2-Sided) 95% 1.175 to 2.033
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.596
	Confidence Interval	(2-Sided) 95% 1.088 to 2.340
	Parameter Dispersion	Type: Value:
	Estimation Comments

88. Secondary Outcome

Title	Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level
Description	Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of <0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of
Time Frame	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

Outcome Measure Data

Analysis Population Description
Patients in evaluable sample with composite outcome data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1291
Number [participants]	323 22.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.621
	Confidence Interval	(2-Sided) 95% 1.152 to 2.281
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.898
	Confidence Interval	(2-Sided) 95% 1.209 to 2.979
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.680
	Confidence Interval	(2-Sided) 95% 1.200 to 5.984
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.438
	Confidence Interval	(2-Sided) 95% 0.291 to 0.660
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.053
	Confidence Interval	(2-Sided) 95% 1.295 to 3.256
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.558
	Confidence Interval	(2-Sided) 95% 0.332 to 0.939
	Parameter Dispersion	Type: Value:
	Estimation Comments

89. Secondary Outcome

Title	Patient-level Predictors for All-cause Mortality
Description	Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes. Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
Measure Participants	1272
Number [participants]	1272 87.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Patient level predictor: History of anemia at enrollment
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0116
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.2064
	Confidence Interval	(2-Sided) 95% 1.1931 to 4.0803
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Liver/renal/cardiac comorbidity as patient level predictor
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0057
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.3049
	Confidence Interval	(2-Sided) 95% 1.2754 to 4.1656
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Poor performance (ECOG >=2) during study as patient level predictor
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	17.5350
	Confidence Interval	(2-Sided) 95% 8.2159 to 37.4243
	Parameter Dispersion	Type: Value:
	Estimation Comments

90. Primary Outcome

Title	EP2006 Day of Initiation: Cycle Distribution
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery. Table presents number of cycles by day after chemotherapy.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Cycles of patients in evaluable sample with day of study drug initiation

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	5930
day 0	795
day1	1818
day 2	793
day 3	541
day 4	270
day 5	404
day 6	400
day 7	429
day 8	231
day 9	59
day10	49
day11	36
≥day12	105

91. Primary Outcome

Title	EP2006 Cycles by Treatment Duration
Description	Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery
Time Frame	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

Outcome Measure Data

Analysis Population Description
All cycles from patients in the evaluable sample with study drug duration

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
Measure cycles	5942
1 day	211
2 days	339
3 days	729
4 days	422
5 days	2718
6 days	385
7 days	682
8 days	115
9 days	53
10 days	120
11 days	13
12 days	20
13 days	8
14 days	105
>=15 days	22

92. Primary Outcome

Title	Incidence of Outcomes
Description	Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Measure Participants	1447
CIN grade 4	13.2 0.9%
FN	5.9 0.4%
CIN/FN related Hospitalization	6.1 0.4%
CIN/FN-related chemotherapy disturbance	9.5 0.7%
Composite^	22.3 1.5%

93. Secondary Outcome

Title	Patient-level Predictor for Cancer-related Mortality
Description	Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes. Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.
Time Frame	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

Outcome Measure Data

Analysis Population Description
Evaluable sample with data

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
Measure Participants	1385
Number [participants]	1385 95.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Female gender as patient-level predictor for cancer-related mortality
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	14.8703
	Confidence Interval	(2-Sided) 95% 5.9567 to 37.1225
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EP2006
	Comments	Poor performance (ECOG >=2) during study as patient-level predictor
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	14.8703
	Confidence Interval	(2-Sided) 95% 5.9567 to 37.1225
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

	EP2006
Time Frame	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
Adverse Event Reporting Description	The occurrence of adverse drug reactions (ADRs) not including not-related (S)AEs was sought by non-directive questioning of the patient at each visit during the study. Only Adverse events with a suspected relationship to EP2006 were collected.

Arm/Group Title	EP2006
Arm/Group Description	Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	EP2006
	Affected / at Risk (%)	# Events
Total	4/1496 (0.3%)
Immune system disorders
Drug hypersensitivity	1/1496 (0.1%)	1
Infections and infestations
Vulvul abscess	1/1496 (0.1%)	1
Musculoskeletal and connective tissue disorders
Bone pain	1/1496 (0.1%)	1
Nervous system disorders
Loss of consciousness	1/1496 (0.1%)	1
Other (Not Including Serious) Adverse Events
	EP2006
	Affected / at Risk (%)	# Events
Total	36/1496 (2.4%)
Musculoskeletal and connective tissue disorders
Bone pain	24/1496 (1.6%)	33
Arthralgia	12/1496 (0.8%)	21
Myalgia	9/1496 (0.6%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor is the sole owner of all data, results and any work summarizing the Study to which this agreement refers, and it should be noted that the Investigator agrees to their publication by Sponsor in any scientific or medical journal chosen by Sponsor. It should be noted that the Investigator may not make any communications or publications relating to the Study which forms the basis of this agreement, without the prior written agreement of the Sponsor.

Results Point of Contact

Name/Title	Andriy Krendyukov, Global Medical Director
Organization	Sandoz GmBH
Phone	+49 8024 4764855
Email	andriy.krendyukov@sandoz.com

Responsible Party:

Sandoz

ClinicalTrials.gov Identifier:

NCT01459653

Other Study ID Numbers:

EP06-502

First Posted:

Oct 25, 2011

Last Update Posted:

Jan 11, 2016

Last Verified:

Dec 1, 2015