| Primary | Chemotherapy Toxicity (%FN Risk) | 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; | 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. | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| | | Title | Denominators | Categories |
|---|
| Low (<10%) | | | | Medium (10-20%) | | | | High (>20%) | | |
| |
| Primary | Cancer Treatment Type - Ever Received During Study | 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; | 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). | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Fever and Infections Ever During the Study | 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; | 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). | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Clinical Events Ever During Study (Frequency Threshold: 5%) | 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 | 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) | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Type of EP2006 Prophylaxis | 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. | 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. | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Type of EP2006 Prophylaxis 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. | Evaluable sample by gender | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Male | Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Female | Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Type of EP 2006 Prophylaxis by Age Group | 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. | | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: <65 Years | Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: >=65 Years | Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Type of EP 2006 Prophylaxis 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. | Evaluable sample by tumor type | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Solid Tumor | Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Hematological Tumor | Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Concomitant Antibiotic Prophylaxis | 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. | | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (All Cycles) | 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. | All cycles from patients in the evaluable sample | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (Enrollment 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. | Number of participants at enrollment cycle with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 1 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 2 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 3 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 4 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 5 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose (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. | Number of participants at cycle 6 with dose data | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose by Patient Weight: Cycle Level | 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. | | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: <=65kg | Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: >65kg | Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose by Tumor Type: Cycle Level | 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. | | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Solid Tumor | Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Hematological Tumor | Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor) | 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. | Evaluable sample by tumor type | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Solid Tumor | Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Hematological Tumor | Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Dose by Chemotherapy Toxicity: Cycle Level | 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. | | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Risk <10% | Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Risk 10-20% | Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG002 | 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. |
|
| Primary | EP2006 Day of Initiation: All Cycles | 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. | Cycles of patients in evaluable sample with day of initiation of study drug | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 1 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 2 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 3 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 4 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 5 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation: 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. | Cycles of patients in evaluable sample with study drug initiation day at cycle 6 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level | 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. | | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Solid Tumor | Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Hematological Tumor | Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation by Prophylaxis Type: Cycle Level | 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. | | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Primary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN. | | OG001 | EP2006: Secondary Prophylaxis | Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN. |
| |
| Primary | EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level | 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. | | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: <10% Risk | Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: 10-20% Risk | Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG002 | EP2006: >20% Risk | Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Primary | EP2006 Treatment Duration in Any 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. | All cycles from patients in the evaluable sample with study drug duration | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 1 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 2 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 3 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 4 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 5 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Treatment 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. | Cycles of participants in evaluable sample with study drug duration in cycle 6 | Posted | | Mean | Standard Deviation | days | | 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. | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Duration by Tumor Type: Cycle Level | 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. | Evaluable sample by tumor type with data | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Solid Tumor | Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Hematological Tumor | Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Duration by Prophylaxis Type: Cycle Level | 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. | | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: Primary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN. | | OG001 | EP2006: Secondary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN. |
| |
| Primary | EP2006 Duration by Chemotherapy Toxicity: Cycle Level | 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. | | Posted | | Mean | Standard Deviation | days | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: <10% Risk | Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: 10-20% Risk | Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG002 | EP2006: >20% Risk | Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Primary | Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline | 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 | | Posted | | Number | | percentage of participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline | 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 | Patients with chemotherapy risk 10-20% in evaluable sample | Posted | | Number | | percentage of patients | | Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Cohort Identification | 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 | 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). | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Characteristics of Clusters: Hemoglobin 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. | 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. | Posted | | Mean | Standard Deviation | g/dL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Group 2 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Patient Risk Score (PRS) for All Patients | 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 | | Posted | | Mean | Standard Deviation | Scores on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk 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 | Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type | Posted | | Mean | Standard Deviation | Scores on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - All Patients | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients). | |
|
| Primary | Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk | 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 | | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006, >20% Chemo-associated FN Risk | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk) | | OG001 | EP2006, 10-20% Chemo-associated FN Risk | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk). | | OG002 | EP2006, <10% Chemo-associated FN Risk | |
|
| Primary | Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result 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 | Evaluable sample: total and by tumor type | Posted | | Number | | percentage of patients | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: All Patients | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Solid Tumor | Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Primary | EP2006 Day of Initiation Relative to Guidelines by Cancer 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. ^ 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 | 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. | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006: EP2006 Initiation During Chemotherapy (Day 0) | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0). | | OG001 |
|
| Primary | GCSF Initiation Score (GIS) | 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 | 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) | Posted | | Number | | Percent of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | 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 | Patients in the evaluable sample with a GCSF persistence score (GPS). | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | GCSF Congruence Score (GCS) | 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); | Evaluable sample with GCSF congruence score by tumor type | Posted | | Mean | Standard Deviation | scores on a scale | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - All Patients | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Solid Tumor | Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Primary | Absolute Neutrophil Count (ANC) at EP2006 Initiation | Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. | Number of patients in evaluable sample with initial ANC result | Posted | | Mean | Standard Deviation | Per mm^3 | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Absolute Neutrophil Count (ANC) Across All Cycles | 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. | | Posted | | Mean | Standard Deviation | Per mm^3 | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 Cycles | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Number of Patients With CIN/FN Episodes: Patient Level | 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. | | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | CIN/FN Episodes: Cycle Level | 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]) | Number of cycles in evaluable sample | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 Cycle Level | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Incidence of Outcomes by Chemotherapy Risk: Patient Level | 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). | Evaluable sample by chemotherapy risk | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Low (<10%) Risk | Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Medium (10-20%) Risk | |
|
| Primary | Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level | 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). | Evaluable sample by prophylaxis type | Posted | | Number | | Percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Primary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN | | OG001 | EP2006: Secondary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN |
| |
| Primary | Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level | 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). | Evaluable sample by prophylaxis decision (relative to guidelines) | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Undertreated | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines | | OG001 | EP2006: Correctly Treated |
|
| Primary | Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level | 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). | Evaluable sample by study drug dose | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: 30MIU/Day | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day | | OG001 | EP2006: 48MIU/Day | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day |
|
| Primary | Incidence of Outcomes by Mean GIS: Patient Level | 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). | Evaluable sample by mean GIS | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Mean GIS 0-0.5 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5 | | OG001 | EP2006: Mean GIS 0.51-0.99 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99 |
|
| Primary | Incidence of Outcomes: Cycles Level | 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). | | Posted | | Number | | Percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level | 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) | 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. | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Day 0 (During Chemotherapy) | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy) |
|
| Primary | Incidence of Outcomes by Study Drug Duration: Cycle Level | 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; | 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. | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: 1-3 Days Duration | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration. | | OG001 | EP2006: 4-5 Days Duration | |
|
| Primary | Number of Patients by Cause of Death | 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. | Safety population, i.e. all patients who received at least one dose of study drug | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or 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 | Evaluable sample by any/no grade 4 CIN/FN | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Any Grade 4 CIN/FN | Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: No Grade 4 CIN/FN | Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Number of Participants With All-cause Mortality by 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 | Evaluable sample by any or no CIN/FN related chemotherapy disturbance. | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Any CIN/FN-related Chemotherapy Disturbance | Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: no CIN/FN-related Chemotherapy Disturbance | Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Primary | Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or 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 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 | Evaluable sample by any/no grade 4 CIN or FN with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Any Grade 4 CIN/FN | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN | | OG001 | EP2006: No Grade 4 CIN/FN | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN |
| |
| Primary | Number of Participants With Cancer-related Mortality by Any 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 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 | Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Any CIN/FN-related Chemotherapy Disturbance | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance | | OG001 | EP2006: No CIN/FN-related Chemotherapy Disturbance | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance |
|
| Primary | Number of Participants With Any CIN/FN-related Chemotherapy Disturbance 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 | Evaluable sample by prophylaxis type | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Primary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN. | | OG001 | EP2006: Secondary Prophylaxis | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN |
| |
| Primary | Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision | 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 | Evaluable sample by treatment decision with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006: Undertreated | Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006: Correctly Treated | Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | |
|
| Primary | Predictors of Absolute Neutrophil Count | 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 | Cycles for patients in evaluable sample with data | Posted | | Number | | participants | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count | 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 | | Posted | | Number | | participants | | 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 | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Characteristics of Clusters: 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 | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Group 2 |
|
| Secondary | Characteristics of Clusters: 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 | 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. | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Group 2 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Characteristics of Clusters: 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 | 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. | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Group 2 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Secondary | Characteristics of Clusters: 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 | 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. | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | EP2006 - Group 1 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | | OG001 | EP2006 - Group 2 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
|
| Secondary | Modeling Grade 4 CIN Episode: Cycle Level | 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 | Number of cycles in evaluable sample with any grade 4 CIN data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling Grade 4 CIN Episode: Patient Level | 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 | Evaluable sample with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling FN Episode: Cycle Level | 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 | Number of cycles of patients in evaluable sample with FN episode data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling FN Episode: Patient Level | 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 | Evaluable sample with FN episode data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling CIN/FN-related Hospitalization: Cycle Level | 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. | Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling CIN/FN-related Hospitalization: Patient Level | 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. | Evaluable sample with CIN/FN-related hospitalization data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level | 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 | Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors) | 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 | Evaluable sample with CIN/FN-related chemotherapy disturbance data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level | 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. | Cycles of patients from evaluable sample with composite outcome data | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level | 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 | Patients in evaluable sample with composite outcome data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Patient-level Predictors for All-cause Mortality | 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 | Evaluable sample with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN |
| |
| Primary | EP2006 Day of Initiation: Cycle Distribution | 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. | Cycles of patients in evaluable sample with day of study drug initiation | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | EP2006 Cycles by Treatment 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 | All cycles from patients in the evaluable sample with study drug duration | Posted | | Number | | cycles | | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | Participants | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Primary | Incidence of Outcomes | 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). | | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. |
| |
| Secondary | Patient-level Predictor for Cancer-related Mortality | 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. | Evaluable sample with data | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | EP2006 | Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN |
| |