Trial Outcomes & Findings for Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (NCT NCT01459653)

NCT ID: NCT01459653

Last Updated: 2016-01-11

Results Overview

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;

• Recruitment status: COMPLETED
• Target enrollment: 1496 participants
• Primary outcome timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
• Results posted on: 2016-01-11

Participant Flow

Participant milestones

Measure	EP2006 Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Overall Study STARTED	1496
Overall Study COMPLETED	828
Overall Study NOT COMPLETED	668

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	EP2006, Evaluable Sample n=1447 Participants 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.
Age, Continuous	61.3 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	886 Participants n=5 Participants
Sex: Female, Male Male	561 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1042 participants n=5 Participants
Race/Ethnicity, Customized African	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Race/Ethnicity, Customized Missing	395 participants n=5 Participants
Region of Enrollment France	395 participants n=5 Participants
Region of Enrollment Hungary	143 participants n=5 Participants
Region of Enrollment Czech Republic	50 participants n=5 Participants
Region of Enrollment Spain	116 participants n=5 Participants
Region of Enrollment Poland	286 participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants
Region of Enrollment Romania	64 participants n=5 Participants
Region of Enrollment Austria	27 participants n=5 Participants
Region of Enrollment Germany	145 participants n=5 Participants
Region of Enrollment United Kingdom	32 participants n=5 Participants
Region of Enrollment Switzerland	11 participants n=5 Participants
Region of Enrollment Italy	175 participants n=5 Participants
Height	165.6 cm STANDARD_DEVIATION 8.5 • n=5 Participants
Weight	72.1 kg STANDARD_DEVIATION 15.0 • n=5 Participants
Body-Mass Index (BMI)	26.3 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants
Medical history Bone pain	116 participants n=5 Participants
Medical history Joint pain	78 participants n=5 Participants
Medical history Muscle pain	31 participants n=5 Participants
Medical history Headache	28 participants n=5 Participants
Medical history Epistaxis	8 participants n=5 Participants
Medical history GI bleeding	7 participants n=5 Participants
Medical history Skin hemorrhage	1 participants n=5 Participants
Comorbidities Hypertension	458 participants n=5 Participants
Comorbidities Anemia	138 participants n=5 Participants
Comorbidities Diabetes Type II	122 participants n=5 Participants
Comorbidities Coronary disease	93 participants n=5 Participants
Comorbidities Allergies	90 participants n=5 Participants
Comorbidities COPD	86 participants n=5 Participants
History of repeated infections History of any repeated infection	35 participants n=5 Participants
History of repeated infections Type of repeated infection (chronic)	8 participants n=5 Participants
History of repeated infections Type of repeated infection (recurrent, acute)	27 participants n=5 Participants
History of repeated infections 1 infectious episode in past 3 months	15 participants n=5 Participants
History of repeated infections 2 infectious episodes in past 3 months	7 participants n=5 Participants
History of repeated infections 3 or more infectious episodes in past 3 months	3 participants n=5 Participants
Cancer type Breast	466 participants n=5 Participants
Cancer type Lung	345 participants n=5 Participants
Cancer type Lymphoma (DLBCL)	245 participants n=5 Participants
Cancer type Ovarian	140 participants n=5 Participants
Cancer type Prostate	102 participants n=5 Participants
Cancer type Multiple myeloma	85 participants n=5 Participants
Cancer type Bladder	64 participants n=5 Participants
Cancer stage & type Breast (stage III, n=466)	267 participants n=5 Participants
Cancer stage & type Breast (stage IV, n=466)	194 participants n=5 Participants
Cancer stage & type Lung (stage III, n=345)	101 participants n=5 Participants
Cancer stage & type Lung (stage IV, n=345)	241 participants n=5 Participants
Cancer stage & type Lymphoma (DLBCL) (stage III, n=245)	103 participants n=5 Participants
Cancer stage & type Lymphoma (DLBCL) (stage IV, n=245)	135 participants n=5 Participants
Cancer stage & type Ovarian (stage III, n=140)	63 participants n=5 Participants
Cancer stage & type Ovarian (stage IV, n=140)	77 participants n=5 Participants
Cancer stage & type Prostate (stage III, n=102)	7 participants n=5 Participants
Cancer stage & type Prostate (stage IV, n=102)	95 participants n=5 Participants
Cancer stage & type Multiple myeloma (stage III, n=85)	53 participants n=5 Participants
Cancer stage & type Multiple myeloma (stage IV, n=85)	16 participants n=5 Participants
Cancer stage & type Bladder (stage III, n=64)	16 participants n=5 Participants
Cancer stage & type Bladder (stage IV, n=64)	48 participants n=5 Participants
Cancer stage & type Overall, Stage III	610 participants n=5 Participants
Cancer stage & type Overall, Stage IV	806 participants n=5 Participants
Cancer stage & type Breast (unknown, n=466)	5 participants n=5 Participants
Cancer stage & type Lung (unknown, n=345)	3 participants n=5 Participants
Cancer stage & type Lymphoma (DLBCL) (unknown, n=245)	7 participants n=5 Participants
Cancer stage & type Multiple myeloma (unknown, N=85)	16 participants n=5 Participants
Cancer stage & type Overall, unknown	31 participants n=5 Participants
Prior cancer treatments None	518 participants n=5 Participants
Prior cancer treatments Surgery	472 participants n=5 Participants
Prior cancer treatments Chemotherapy	460 participants n=5 Participants
Prior cancer treatments Radiation therapy	274 participants n=5 Participants
Prior cancer treatments Hormonal therapy	198 participants n=5 Participants
Prior cancer treatments Targeted therapy	45 participants n=5 Participants
Prior cancer treatments Bone marrow transplant	12 participants n=5 Participants
Prior cancer treatments Other (including CAM)	25 participants n=5 Participants
Prior cancer treatments Prior Chemotherapy, Adjuvant	196 participants n=5 Participants
Prior cancer treatments Prior Chemotherapy, metastatic setting	206 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (1)	1046 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (2)	221 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (3)	93 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (4)	44 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (5)	26 participants n=5 Participants
Cancer treatment Chemotherapy cycle at study entry (6)	17 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior CIN grade 4 episodes (any)	106 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior CIN grade 4 episodes (1)	79 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior CIN grade 4 episodes (2)	5 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior CIN grade 4 episodes (≥3)	15 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior CIN grade 4 episodes (missing)	7 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior FN	27 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Hospitalization for CIN/FN	33 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Any chemotherapy disturbance due to CIN/FN	48 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (CSF therapy)	55 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (antibiotics)	44 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (antiviral)	0 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (antifungal)	7 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (corticosteroids)	5 participants n=5 Participants
History of prior CIN/FN and prior CIN/FN treatments Prior treatments for CIN/FN (antipyretics)	12 participants n=5 Participants
Treatment(s) for prior infections Antibiotic	33 participants n=5 Participants
Treatment(s) for prior infections Antifungal	2 participants n=5 Participants
Treatment(s) for prior infections GCSF	2 participants n=5 Participants
Treatment(s) for prior infections Antiviral	1 participants n=5 Participants
ECOG score at enrollment ECOG Score 0	553 participants n=5 Participants
ECOG score at enrollment ECOG Score 1	652 participants n=5 Participants
ECOG score at enrollment ECOG Score 2	121 participants n=5 Participants
ECOG score at enrollment ECOG Score 3	26 participants n=5 Participants
ECOG score at enrollment ECOG Score 4	1 participants n=5 Participants
ECOG score at enrollment ECOG score Missing	94 participants n=5 Participants
Cause(s) of prior repeated infections Respiratory infections	15 participants n=5 Participants
Cause(s) of prior repeated infections Neutropenia	11 participants n=5 Participants
Cause(s) of prior repeated infections Cancer	8 participants n=5 Participants
Cause(s) of prior repeated infections High use of antibiotics	3 participants n=5 Participants
Cause(s) of prior repeated infections Urinary tract infections	3 participants n=5 Participants
Cause(s) of prior repeated infections Immunosuppression	3 participants n=5 Participants
Cause(s) of prior repeated infections Diabetes mellitus	2 participants n=5 Participants
History of prior clinical events Bone pain	116 participants n=5 Participants
History of prior clinical events Muscle pain	31 participants n=5 Participants
History of prior clinical events Joint pain	78 participants n=5 Participants
History of prior clinical events Headache	28 participants n=5 Participants
Cancer stage by tumor type Solid tumor (n=1117), Stage III	454 participants n=5 Participants
Cancer stage by tumor type Solid tumor (n=1117), Stage IV	655 participants n=5 Participants
Cancer stage by tumor type Hematological tumor (n=330), Stage III	156 participants n=5 Participants
Cancer stage by tumor type Hematological tumor (n=330), Stage IV	151 participants n=5 Participants
Cancer stage by tumor type Solid tumor (n=1117), Stage unknown	8 participants n=5 Participants
Cancer stage by tumor type Hematological tumor (n=330), Stage unknown	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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;

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Chemotherapy Toxicity (%FN Risk) Low (<10%)	154 participants	—	—
Chemotherapy Toxicity (%FN Risk) Medium (10-20%)	650 participants	—	—
Chemotherapy Toxicity (%FN Risk) High (>20%)	640 participants	—	—
Chemotherapy Toxicity (%FN Risk) Missing	3 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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).

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;

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Cancer Treatment Type - Ever Received During Study Surgery	100 participants	—	—
Cancer Treatment Type - Ever Received During Study Radiotherapy	102 participants	—	—
Cancer Treatment Type - Ever Received During Study Hormonal therapy	85 participants	—	—
Cancer Treatment Type - Ever Received During Study Targeted treatment	89 participants	—	—
Cancer Treatment Type - Ever Received During Study Bone marrow transplant	31 participants	—	—
Cancer Treatment Type - Ever Received During Study Other (e.g., CAM)	98 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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).

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;

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Fever and Infections Ever During the Study Fever ever during study	76 participants	—	—
Fever and Infections Ever During the Study Infections ever during study	231 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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)

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

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Clinical Events Ever During Study (Frequency Threshold: 5%) Bone pain	357 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Thrombocytopenia	230 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Serum LDH increase	222 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Muscle pain	210 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Joint pain	200 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Serum GGT increase	178 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Serum ALP increase	168 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Other neurological symptoms	102 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Headache	100 participants	—	—
Clinical Events Ever During Study (Frequency Threshold: 5%) Blood uric acid increase	88 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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.

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.

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Type of EP2006 Prophylaxis Primary (initiated in cycle1)	1046 participants	—	—
Type of EP2006 Prophylaxis Secondary (initiated in cycle2 or later)	401 participants	—	—
Type of EP2006 Prophylaxis Delayed primary	245 participants	—	—
Type of EP2006 Prophylaxis True secondary	156 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by gender

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.

Outcome measures

Measure	EP2006 n=561 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=886 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Type of EP2006 Prophylaxis by Gender Primary (initiated in cycle1)	397 participants	649 participants	—
Type of EP2006 Prophylaxis by Gender Secondary (initiated in cycle2 or later)	164 participants	237 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by age

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.

Outcome measures

Measure	EP2006 n=849 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=598 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Type of EP 2006 Prophylaxis by Age Group Primary (initiated in cycle1)	626 participants	420 participants	—
Type of EP 2006 Prophylaxis by Age Group Secondary, initiated in cycle2 or later	223 participants	178 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by tumor type

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.

Outcome measures

Measure	EP2006 n=1117 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=330 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Type of EP 2006 Prophylaxis by Tumor Type Primary (initiated in cycle1)	801 participants	245 participants	—
Type of EP 2006 Prophylaxis by Tumor Type Secondary (initiated in ≥cycle2)	316 participants	85 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Concomitant Antibiotic Prophylaxis Concomitant antibiotic prophylaxis	175 participants	—	—
Concomitant Antibiotic Prophylaxis No Concomitant antibiotic prophylaxis	1261 participants	—	—
Concomitant Antibiotic Prophylaxis Missing	11 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: All cycles from patients in the evaluable sample

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.

Outcome measures

Measure	EP2006 n=5986 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (All Cycles) 30 MIU/day	3182 cycles	—	—
EP2006 Dose (All Cycles) 48 MIU/day	2756 cycles	—	—
EP2006 Dose (All Cycles) Other	48 cycles	—	—

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at enrollment cycle with dose data

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.

Outcome measures

Measure	EP2006 n=1434 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Enrollment Cycle) 30 MIU/day	815 participants	—	—
EP2006 Dose (Enrollment Cycle) 48 MIU/day	610 participants	—	—
EP2006 Dose (Enrollment Cycle) Other	9 participants	—	—

PRIMARY outcome

Timeframe: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 1 with dose data

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.

Outcome measures

Measure	EP2006 n=1036 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 1) 30 MIU/day	593 participants	—	—
EP2006 Dose (Cycle 1) 48 MIU/day	434 participants	—	—
EP2006 Dose (Cycle 1) Other	9 participants	—	—

PRIMARY outcome

Timeframe: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 2 with dose data

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.

Outcome measures

Measure	EP2006 n=1143 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 2) 30 MIU/day	627 participants	—	—
EP2006 Dose (Cycle 2) 48 MIU/day	507 participants	—	—
EP2006 Dose (Cycle 2) Other	9 participants	—	—

PRIMARY outcome

Timeframe: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 3 with dose data

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.

Outcome measures

Measure	EP2006 n=1125 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 3) 30 MIU/day	597 participants	—	—
EP2006 Dose (Cycle 3) 48 MIU/day	519 participants	—	—
EP2006 Dose (Cycle 3) Other	9 participants	—	—

PRIMARY outcome

Timeframe: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 4 with dose data

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.

Outcome measures

Measure	EP2006 n=1045 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 4) 30 MIU/day	548 participants	—	—
EP2006 Dose (Cycle 4) 48 MIU/day	490 participants	—	—
EP2006 Dose (Cycle 4) Other	7 participants	—	—

PRIMARY outcome

Timeframe: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 5 with dose data

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.

Outcome measures

Measure	EP2006 n=862 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 5) 30 MIU/day	431 participants	—	—
EP2006 Dose (Cycle 5) 48 MIU/day	424 participants	—	—
EP2006 Dose (Cycle 5) Other	7 participants	—	—

PRIMARY outcome

Timeframe: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of participants at cycle 6 with dose data

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.

Outcome measures

Measure	EP2006 n=775 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose (Cycle 6) 30 MIU/day	386 participants	—	—
EP2006 Dose (Cycle 6) 48 MIU/day	382 participants	—	—
EP2006 Dose (Cycle 6) Other	7 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: All cycles treated

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.

Outcome measures

Measure	EP2006 n=2272 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=3666 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose by Patient Weight: Cycle Level 30 MIU/day	1501 cycles	1681 cycles	—
EP2006 Dose by Patient Weight: Cycle Level 48 MIU/day	771 cycles	1985 cycles	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=4609 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1329 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose by Tumor Type: Cycle Level 30 MIU/day	2296 cycles	886 cycles	—
EP2006 Dose by Tumor Type: Cycle Level 48 MIU/day	2313 cycles	443 cycles	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by tumor type

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.

Outcome measures

Measure	EP2006 n=1117 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=330 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor) ≤65 kg	441 participants	135 participants	—
Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor) >65 kg	676 participants	195 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=546 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=2534 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=2843 cycles Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Dose by Chemotherapy Toxicity: Cycle Level 30 MIU/day	357 cycles	1375 cycles	1441 cycles
EP2006 Dose by Chemotherapy Toxicity: Cycle Level 48 MIU/day	189 cycles	1159 cycles	1402 cycles

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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.

Outcome measures

Measure	EP2006 n=5930 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: All Cycles	3.1 days Standard Deviation 3.0	—	—

PRIMARY outcome

Timeframe: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1017 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 1	3.4 days Standard Deviation 3.2	—	—

PRIMARY outcome

Timeframe: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1132 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 2	3.1 days Standard Deviation 3.0	—	—

PRIMARY outcome

Timeframe: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1111 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 3	3.0 days Standard Deviation 2.9	—	—

PRIMARY outcome

Timeframe: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1038 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 4	3.0 days Standard Deviation 2.9	—	—

PRIMARY outcome

Timeframe: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=858 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 5	2.9 days Standard Deviation 2.9	—	—

PRIMARY outcome

Timeframe: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=774 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle 6	3.0 days Standard Deviation 2.9	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=4614 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1316 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level	2.6 days Standard Deviation 2.7	4.8 days Standard Deviation 3.3	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=4700 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1230 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation by Prophylaxis Type: Cycle Level	3.2 days Standard Deviation 3.0	2.6 days Standard Deviation 2.9	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=542 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=2504 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=2869 cycles Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level	2.3 days Standard Deviation 2.9	3.0 days Standard Deviation 3.0	3.3 days Standard Deviation 3.0

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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.

Outcome measures

Measure	EP2006 n=5942 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Any Cycle	5.1 days Standard Deviation 2.3	—	—

PRIMARY outcome

Timeframe: Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1025 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 1	5.2 days Standard Deviation 2.2	—	—

PRIMARY outcome

Timeframe: Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1134 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 2	5.1 days Standard Deviation 2.3	—	—

PRIMARY outcome

Timeframe: Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1117 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 3	5.2 days Standard Deviation 2.3	—	—

PRIMARY outcome

Timeframe: Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=1039 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 4	5.1 days Standard Deviation 2.3	—	—

PRIMARY outcome

Timeframe: Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=856 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 5	5.1 days Standard Deviation 2.4	—	—

PRIMARY outcome

Timeframe: Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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.

Outcome measures

Measure	EP2006 n=771 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Treatment Duration in Cycle 6	5.0 days Standard Deviation 2.4	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by tumor type with data

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.

Outcome measures

Measure	EP2006 n=4619 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1323 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Duration by Tumor Type: Cycle Level	5.14 days Standard Deviation 2.24	5.03 days Standard Deviation 2.56	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=4703 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1239 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Duration by Prophylaxis Type: Cycle Level	5.1 days Standard Deviation 2.2	5.2 days Standard Deviation 2.7	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=541 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=2513 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=2875 cycles Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Duration by Chemotherapy Toxicity: Cycle Level	4.6 days Standard Deviation 2.4	5.0 days Standard Deviation 2.2	5.3 days Standard Deviation 2.4

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Evaluable sample

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

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Age >=65 years	41.3 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Advanced disease*	13.7 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline History of FN	1.9 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline No antibiotic prophylaxis	87.8 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Poor performance and/or nutritional status	13.1 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Female gender	61.2 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Hb < 12 g/dL	39.6 percentage of participants	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline Renal, CV, or liver disease	23.1 percentage of participants	—	—

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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

Outcome measures

Measure	EP2006 n=650 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline History of FN	2.0 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Renal, CV, or liver disease	26.9 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Age >=65 years	44.6 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Advanced disease*	20.8 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline No antibiotic prophylaxis	91.3 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Poor performance and/or nutritional status	13.3 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Female gender	57.8 percentage of patients	—	—
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline Hb < 12 g/dL	45.9 percentage of patients	—	—

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Evaluable sample

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

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient Risk Score (PRS) for All Patients	2.9 Scores on a scale Standard Deviation 2.0	—	—

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

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

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

Outcome measures

Measure	EP2006 n=650 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=568 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=82 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type	3.3 Scores on a scale Standard Deviation 2.0	3.2 Scores on a scale Standard Deviation 1.9	3.4 Scores on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

Outcome measures

Measure	EP2006 n=640 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=650 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=154 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Primary prophylaxis: Correctly treated (%)	35.0 percentage of participants	17.3 percentage of participants	0 percentage of participants
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Primary prophylaxis:Over-treated (%)	0 percentage of participants	13.0 percentage of participants	6.9 percentage of participants
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Secondary prophylaxis: Correctly treated (%)	0 percentage of participants	3.1 percentage of participants	1.2 percentage of participants
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Secondary prophylaxis: Under-treated (%)	9.3 percentage of participants	8.1 percentage of participants	0 percentage of participants
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Secondary prophylaxis: Over-treated (%)	0 percentage of participants	3.5 percentage of participants	2.6 percentage of participants
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk Primary prophylaxis: Under-treated (%)	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample: total and by tumor type

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

Outcome measures

Measure	EP2006 n=1444 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1115 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=329 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type Under-treated (%)	17.3 percentage of patients	16.3 percentage of patients	21.0 percentage of patients
Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type Correctly or Over-treated (%)	82.5 percentage of patients	83.7 percentage of patients	79.0 percentage of patients

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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.

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

Outcome measures

Measure	EP2006 n=795 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=3320 cycles Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=1815 cycles Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Multiple myeloma	32 cycles	167 cycles	37 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Breast	178 cycles	1410 cycles	624 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Lung	305 cycles	691 cycles	225 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Lymphoma (DLBCL)	23 cycles	386 cycles	671 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Ovarian	109 cycles	332 cycles	119 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Prostate	26 cycles	278 cycles	95 cycles
EP2006 Day of Initiation Relative to Guidelines by Cancer Type Bladder	122 cycles	56 cycles	44 cycles

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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)

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

Outcome measures

Measure	EP2006 n=1423 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
GCSF Initiation Score (GIS) GIS score 0 (%)	15.9 Percent of participants	—	—
GCSF Initiation Score (GIS) GIS score 0.50 (%)	11.5 Percent of participants	—	—
GCSF Initiation Score (GIS) GIS score 0.75 (%)	16.6 Percent of participants	—	—
GCSF Initiation Score (GIS) GIS score 1.0 (%)	56.0 Percent of participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=1295 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
GCSF Persistence Score (GPS) GPS score 0	123 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.33	2 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.50	3 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.60	2 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.67	4 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.75	1 participants	—	—
GCSF Persistence Score (GPS) GPS score 0.80	3 participants	—	—
GCSF Persistence Score (GPS) GPS score 1	1157 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with GCSF congruence score by tumor type

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);

Outcome measures

Measure	EP2006 n=1278 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1015 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=263 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
GCSF Congruence Score (GCS)	2.5 scores on a scale Standard Deviation 0.6	2.5 scores on a scale Standard Deviation 0.6	2.5 scores on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: Number of patients in evaluable sample with initial ANC result

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.

Outcome measures

Measure	EP2006 n=1283 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Absolute Neutrophil Count (ANC) at EP2006 Initiation	4429.7 Per mm^3 Standard Deviation 4725.8	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=7792 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Absolute Neutrophil Count (ANC) Across All Cycles	4585.6 Per mm^3 Standard Deviation 3889.8	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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.

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Patients With CIN/FN Episodes: Patient Level CIN any grade	504 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level CIN grade 3/4	332 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level CIN grade 4	191 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level FN	86 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level CIN/FN-related hospitalization	88 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level CIN/FN-related chemotherapy disturbance	138 participants	—	—
Number of Patients With CIN/FN Episodes: Patient Level Composite	323 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Number of cycles in evaluable sample

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])

Outcome measures

Measure	EP2006 n=7570 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
CIN/FN Episodes: Cycle Level CIN any grade (n=7557)	1083 cycles	—	—
CIN/FN Episodes: Cycle Level CIN grade 3/4 (n=7541)	602 cycles	—	—
CIN/FN Episodes: Cycle Level CIN grade 4 (n=7541)	294 cycles	—	—
CIN/FN Episodes: Cycle Level FN (n=7532)	105 cycles	—	—
CIN/FN Episodes: Cycle Level CIN/FN-RH (n=7531)	111 cycles	—	—
CIN/FN Episodes: Cycle Level CIN/FN-RCD (n=6213)	174 cycles	—	—
CIN/FN Episodes: Cycle Level Composite (n=7570)	507 cycles	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by chemotherapy risk

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).

Outcome measures

Measure	EP2006 n=154 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=650 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=640 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes by Chemotherapy Risk: Patient Level CIN grade 4	7.8 percentage of participants	11.8 percentage of participants	15.9 percentage of participants
Incidence of Outcomes by Chemotherapy Risk: Patient Level FN	3.9 percentage of participants	3.5 percentage of participants	8.9 percentage of participants
Incidence of Outcomes by Chemotherapy Risk: Patient Level Composite^	16.9 percentage of participants	20.9 percentage of participants	25.2 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by prophylaxis type

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).

Outcome measures

Measure	EP2006 n=1046 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=401 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level	7.5 Percentage of participants	15.0 Percentage of participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by prophylaxis decision (relative to guidelines)

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).

Outcome measures

Measure	EP2006 n=251 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=817 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=376 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level CIN grade 4	12.0 percentage of participants	16.8 percentage of participants	6.4 percentage of participants
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level FN	5.2 percentage of participants	8.0 percentage of participants	2.1 percentage of participants
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level CIN/FN-related hospitalization	8.0 percentage of participants	7.1 percentage of participants	2.7 percentage of participants
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level CIN/FN-related chemotherapy disturbance	14.7 percentage of participants	8.8 percentage of participants	7.7 percentage of participants
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level Composite^	24.7 percentage of participants	26.0 percentage of participants	13.0 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by study drug dose

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).

Outcome measures

Measure	EP2006 n=815 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=610 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level	11.3 percentage of participants	15.9 percentage of participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by mean GIS

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).

Outcome measures

Measure	EP2006 n=390 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=308 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=725 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes by Mean GIS: Patient Level CIN grade 4	17.7 percentage of participants	17.5 percentage of participants	9.2 percentage of participants
Incidence of Outcomes by Mean GIS: Patient Level Composite^	26.9 percentage of participants	24.7 percentage of participants	18.9 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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).

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes: Cycles Level CIN grade 4	3.9 Percentage of participants	—	—
Incidence of Outcomes: Cycles Level FN	1.4 Percentage of participants	—	—
Incidence of Outcomes: Cycles Level CIN/FN-related hospitalization	1.5 Percentage of participants	—	—
Incidence of Outcomes: Cycles Level CIN/FN-related chemotherapy disturbance	2.8 Percentage of participants	—	—
Incidence of Outcomes: Cycles Level Composite^	6.7 Percentage of participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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.

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)

Outcome measures

Measure	EP2006 n=234 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=851 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=473 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level CIN grade 4	3.1 percentage of participants	2.8 percentage of participants	7.3 percentage of participants
Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level FN	1.0 percentage of participants	1.2 percentage of participants	2.1 percentage of participants
Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level Composite^	5.8 percentage of participants	5.4 percentage of participants	9.1 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: 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.

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;

Outcome measures

Measure	EP2006 n=380 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=784 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=419 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes by Study Drug Duration: Cycle Level CIN grade 4	3.6 percentage of participants	3.9 percentage of participants	5.5 percentage of participants
Incidence of Outcomes by Study Drug Duration: Cycle Level FN	1.2 percentage of participants	1.2 percentage of participants	2.2 percentage of participants
Incidence of Outcomes by Study Drug Duration: Cycle Level CIN/FN-related chemotherapy disturbance	2.0 percentage of participants	2.1 percentage of participants	4.7 percentage of participants
Incidence of Outcomes by Study Drug Duration: Cycle Level Composite^	6.0 percentage of participants	5.8 percentage of participants	9.3 percentage of participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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.

Outcome measures

Measure	EP2006 n=1496 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Patients by Cause of Death All cause	61 participants	—	—
Number of Patients by Cause of Death Cancer-related	41 participants	—	—
Number of Patients by Cause of Death Non-cancer related	14 participants	—	—
Number of Patients by Cause of Death Cause of death specified as "unknown"	4 participants	—	—
Number of Patients by Cause of Death Cause of death not documented	2 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by any/no grade 4 CIN/FN

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

Outcome measures

Measure	EP2006 n=221 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1226 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN	10 participants	46 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=138 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1309 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance	3 participants	53 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=221 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1220 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN	6 participants	29 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=138 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=1303 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance	2 participants	33 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by prophylaxis type

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

Outcome measures

Measure	EP2006 n=1046 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=401 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type	78 participants	60 participants	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample by treatment decision with data

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

Outcome measures

Measure	EP2006 n=251 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=817 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% n=376 Participants Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision	37 participants	72 participants	29 participants

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Cycles for patients in evaluable sample with data

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

Outcome measures

Measure	EP2006 n=4333 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Predictors of Absolute Neutrophil Count	1185 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample

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

Outcome measures

Measure	EP2006 n=4333 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count	1185 participants	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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.

Outcome measures

Measure	EP2006 n=5930 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Day of Initiation: Cycle Distribution day 0	795 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day1	1818 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 2	793 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 3	541 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 4	270 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 5	404 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 6	400 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 7	429 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 8	231 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day 9	59 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day10	49 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution day11	36 cycles	—	—
EP2006 Day of Initiation: Cycle Distribution ≥day12	105 cycles	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=5942 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006 Cycles by Treatment Duration 14 days	105 cycles	—	—
EP2006 Cycles by Treatment Duration >=15 days	22 cycles	—	—
EP2006 Cycles by Treatment Duration 1 day	211 cycles	—	—
EP2006 Cycles by Treatment Duration 2 days	339 cycles	—	—
EP2006 Cycles by Treatment Duration 3 days	729 cycles	—	—
EP2006 Cycles by Treatment Duration 4 days	422 cycles	—	—
EP2006 Cycles by Treatment Duration 5 days	2718 cycles	—	—
EP2006 Cycles by Treatment Duration 6 days	385 cycles	—	—
EP2006 Cycles by Treatment Duration 7 days	682 cycles	—	—
EP2006 Cycles by Treatment Duration 8 days	115 cycles	—	—
EP2006 Cycles by Treatment Duration 9 days	53 cycles	—	—
EP2006 Cycles by Treatment Duration 10 days	120 cycles	—	—
EP2006 Cycles by Treatment Duration 11 days	13 cycles	—	—
EP2006 Cycles by Treatment Duration 12 days	20 cycles	—	—
EP2006 Cycles by Treatment Duration 13 days	8 cycles	—	—

PRIMARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample

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).

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Incidence of Outcomes CIN grade 4	13.2 percentage of participants	—	—
Incidence of Outcomes FN	5.9 percentage of participants	—	—
Incidence of Outcomes CIN/FN related Hospitalization	6.1 percentage of participants	—	—
Incidence of Outcomes CIN/FN-related chemotherapy disturbance	9.5 percentage of participants	—	—
Incidence of Outcomes Composite^	22.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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).

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

Outcome measures

Measure	EP2006 n=1447 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Cohort Identification EP2006 - Group 1	1192 participants	—	—
Cohort Identification EP2006 - Group 2	43 participants	—	—
Cohort Identification Missing	212 participants	—	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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.

Outcome measures

Measure	EP2006 n=1175 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=43 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Characteristics of Clusters: Hemoglobin Study Start	12.35 g/dL Standard Deviation 1.80	11.82 g/dL Standard Deviation 1.86	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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

Outcome measures

Measure	EP2006 n=1145 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=39 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Characteristics of Clusters: ECOG Performance Status	0.75 Scores on a scale Standard Deviation 0.72	0.87 Scores on a scale Standard Deviation 0.61	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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

Outcome measures

Measure	EP2006 n=1192 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=41 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Characteristics of Clusters: Cancer Stage Cancer Stage III	511 participants	12 participants	—
Characteristics of Clusters: Cancer Stage Cancer Stage IV	681 participants	29 participants	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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

Outcome measures

Measure	EP2006 n=1192 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=41 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Characteristics of Clusters: History of Antibiotic Use for CIN No history for antibiotic use for CIN	1190 participants	17 participants	—
Characteristics of Clusters: History of Antibiotic Use for CIN History for antibiotic use for CIN (Yes)	2 participants	24 participants	—

SECONDARY outcome

Timeframe: Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.

Population: 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.

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

Outcome measures

Measure	EP2006 n=1192 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female n=41 Participants Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease No Liver, renal and/or cardiovascular disease	931 participants	19 participants	—
Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease Liver, renal and/or cardiovascular disease (Yes)	261 participants	22 participants	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=5514 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling Grade 4 CIN Episode: Cycle Level	294 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with data

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

Outcome measures

Measure	EP2006 n=1323 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling Grade 4 CIN Episode: Patient Level	191 participants	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=6362 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling FN Episode: Cycle Level	105 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with FN episode data

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

Outcome measures

Measure	EP2006 n=1376 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling FN Episode: Patient Level	86 participants	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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.

Outcome measures

Measure	EP2006 n=6928 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling CIN/FN-related Hospitalization: Cycle Level	111 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with CIN/FN-related hospitalization data

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.

Outcome measures

Measure	EP2006 n=1387 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling CIN/FN-related Hospitalization: Patient Level	88 participants	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=3376 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level	174 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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

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

Outcome measures

Measure	EP2006 n=1334 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)	138 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Cycles of patients from evaluable sample with composite outcome data

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.

Outcome measures

Measure	EP2006 n=5193 cycles Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level	507 cycles	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Patients in evaluable sample with composite outcome data

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

Outcome measures

Measure	EP2006 n=1291 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level	323 participants	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with data

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

Outcome measures

Measure	EP2006 n=1272 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient-level Predictors for All-cause Mortality	1272 participants	—	—

SECONDARY outcome

Timeframe: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

Population: Evaluable sample with data

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.

Outcome measures

Measure	EP2006 n=1385 Participants Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Female Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.	EP2006: Risk >20% Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Patient-level Predictor for Cancer-related Mortality	1385 participants	—	—

Adverse Events

EP2006

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	EP2006 n=1496 participants at risk 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.
Immune system disorders Drug hypersensitivity	0.07% 1/1496 • Number of events 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, mean duration of study for 105 days 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.
Infections and infestations Vulvul abscess	0.07% 1/1496 • Number of events 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, mean duration of study for 105 days 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.
Musculoskeletal and connective tissue disorders Bone pain	0.07% 1/1496 • Number of events 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, mean duration of study for 105 days 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.
Nervous system disorders Loss of consciousness	0.07% 1/1496 • Number of events 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, mean duration of study for 105 days 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.

Other adverse events

Measure	EP2006 n=1496 participants at risk 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.
Musculoskeletal and connective tissue disorders Bone pain	1.6% 24/1496 • Number of events 33 • Patients were evaluated at the enrollment cycle and then re-evaluated 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 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.80% 12/1496 • Number of events 21 • Patients were evaluated at the enrollment cycle and then re-evaluated 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 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.
Musculoskeletal and connective tissue disorders Myalgia	0.60% 9/1496 • Number of events 11 • Patients were evaluated at the enrollment cycle and then re-evaluated 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 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.

Additional Information

Andriy Krendyukov, Global Medical Director

Sandoz GmBH

Phone: +49 8024 4764855

Email: andriy.krendyukov@sandoz.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER