Breast Cancer, Chemotherapy Associated Neutropenia
Conditions
Keywords
Filgrastim, G-CSF, neutropenia, supportive care, breast cancer
Brief summary
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Interventions
DRUGEP2006
Eligible patients will be teated with EP2006
DRUGFilgrastim
Eligible patients will be teated with Filgrastim
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy 2. Women ≥ 18 years of age 3. Estimated life expectancy of more than six months
Exclusion criteria
1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry 2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy | 21 days (Cycle 1 of chemotherapy treatment) | Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days of Fever | 21 weeks/ 6 cycles | Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C. |
| Depth of Absolute Neutrophil Count Nadir | Cycle 1/ 21 days | Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1 |
| Incidence of Febrile Neutropenia | 21 weeks/ 6 cycles | Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count \< 0.5\*10\^9 cells/L (both measured on the same day) |
| Frequency of Infections | 21 Weeks/ 6 cycles | Frequency of infections by cycle and across all cycles |
| Incidence of Hospitalizations Due to Febrile Neutropenia | 21 Weeks/ 6 cycles | Incidence of hospitalizations due to Febrile Neutropenia |
| Time to Absolute Neutrophil Count Recovery | Cycle 1/ 21 days | Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2\*10\^9 cells/L after the nadir in cycle 1 |
Countries
Czechia, Hungary, Latvia, Russia, Slovakia, Ukraine
Participant flow
Recruitment details
The study population consisted of women of 18 years or older with histologically proven breast cancer who were eligible for neoadjuvant or adjuvant treatment with TAC chemotherapy. The study was aimed to randomize a total of 192 patients in approximately 65 centers worldwide.
Pre-assignment details
The study started with a screening period of up to 21 days. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations. After completion of the screening period, the patients were randomized to either EP2006 or US-licensed Neupogen® in four groups (see below).
Participants by arm
| Arm | Count |
|---|---|
| EP2006 Patients remained on EP2006 (their initial treatment) throughout the study | 53 |
| EP2006 + Neupogen Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle | 54 |
| Neupogen + EP2006 Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle | 55 |
| Neupogen Patients remained on Neupogen (their initial treatment) throughout the study | 52 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Overall Study | Other Reason | 2 | 2 | 0 | 4 |
| Overall Study | Physician Decision | 1 | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 3 | 2 |
Baseline characteristics
| Characteristic | EP2006 | EP2006 + Neupogen | Neupogen + EP2006 | Neupogen | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 11.16 | 47.5 years STANDARD_DEVIATION 11.64 | 49.7 years STANDARD_DEVIATION 11.05 | 46.9 years STANDARD_DEVIATION 10.91 | 48.9 years STANDARD_DEVIATION 11.26 |
| Sex: Female, Male Female | 53 Participants | 54 Participants | 55 Participants | 52 Participants | 214 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 50 / 53 | 51 / 54 | 52 / 55 | 50 / 52 |
| serious Total, serious adverse events | 6 / 53 | 4 / 54 | 1 / 55 | 3 / 52 |
Outcome results
Primary
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
Time frame: 21 days (Cycle 1 of chemotherapy treatment)
Population: PP population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy | 1.17 Days | Standard Deviation 1.11 |
| Neupogen + Neupogen & EP2006 | Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy | 1.2 Days | Standard Deviation 1.02 |
Secondary
Depth of Absolute Neutrophil Count Nadir
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Time frame: Cycle 1/ 21 days
Population: FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Depth of Absolute Neutrophil Count Nadir | 0.808 10^9 cells/L | Standard Deviation 1.3694 |
| Neupogen + Neupogen & EP2006 | Depth of Absolute Neutrophil Count Nadir | 0.744 10^9 cells/L | Standard Deviation 1.2906 |
| Neupogen + EP2006 | Depth of Absolute Neutrophil Count Nadir | 0.776 10^9 cells/L | Standard Deviation 1.3278 |
Secondary
Frequency of Infections
Frequency of infections by cycle and across all cycles
Time frame: 21 Weeks/ 6 cycles
Population: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 1 - No | 102 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 5 - Yes | 2 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 3 - Yes | 1 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | All Cycles - No | 96 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 5 - No | 101 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 4 - No | 101 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 2 - No | 100 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 4 - Yes | 2 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | All Cycles - Yes | 7 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 6 - Yes | 1 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 2 - Yes | 3 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 1 - Yes | 1 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 6 - No | 102 participants |
| EP2006 + EP2006 & Neupogen | Frequency of Infections | Cycle 3 - No | 102 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 1 - Yes | 3 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 1 - No | 104 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | All Cycles - Yes | 10 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 2 - No | 102 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 2 - Yes | 5 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 3 - No | 107 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 3 - Yes | 0 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 4 - No | 104 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 4 - Yes | 3 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 5 - No | 106 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 5 - Yes | 1 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 6 - No | 106 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | Cycle 6 - Yes | 1 participants |
| Neupogen + Neupogen & EP2006 | Frequency of Infections | All Cycles - No | 97 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 3 - No | 209 participants |
| Neupogen + EP2006 | Frequency of Infections | All Cycles - Yes | 17 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 5 - Yes | 3 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 2 - Yes | 8 participants |
| Neupogen + EP2006 | Frequency of Infections | All Cycles - No | 193 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 6 - No | 208 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 2 - No | 202 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 1 - No | 206 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 4 - No | 205 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 6 - Yes | 2 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 4 - Yes | 5 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 3 - Yes | 1 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 1 - Yes | 4 participants |
| Neupogen + EP2006 | Frequency of Infections | Cycle 5 - No | 207 participants |
Secondary
Incidence of Febrile Neutropenia
Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count \< 0.5\*10\^9 cells/L (both measured on the same day)
Time frame: 21 weeks/ 6 cycles
Population: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 2 - 1 Day duration | 0 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 5 - 0 Days duration | 45 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 3 - 0 Days duration | 51 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 0 Days duration | 50 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 4 - 0 Days duration | 51 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | All Cycles - 1 Day duration | 3 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 1 Day duration | 2 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | All Cycles - 2 Days duration | 0 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | All Cycles - 0 Days duration | 49 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 2 Days duration | 0 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 6 - 1 Day duration | 1 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 2 - 0 Days duration | 52 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 6 - 0 Days duration | 43 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Febrile Neutropenia | Cycle 5 - 1 Day duration | 0 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 5 - 1 Day duration | 1 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 6 - 0 Days duration | 48 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 2 - 1 Day duration | 1 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 4 - 0 Days duration | 51 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 6 - 1 Day duration | 1 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 3 - 0 Days duration | 51 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 2 - 0 Days duration | 51 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 2 Days duration | 0 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 0 Days duration | 49 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | All Cycles - 2 Days duration | 0 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | All Cycles - 1 Day duration | 6 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | All Cycles - 0 Days duration | 46 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 5 - 0 Days duration | 48 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 1 Day duration | 3 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 6 - 0 Days duration | 48 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 5 - 1 Day duration | 0 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 0 Days duration | 54 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 1 Day duration | 0 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 1 - 2 Days duration | 1 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 2 - 0 Days duration | 55 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 2 - 1 Day duration | 0 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 3 - 0 Days duration | 54 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 4 - 0 Days duration | 50 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 5 - 0 Days duration | 48 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | Cycle 6 - 1 Day duration | 0 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | All Cycles - 0 Days duration | 54 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | All Cycles - 1 Day duration | 0 participants |
| Neupogen + EP2006 | Incidence of Febrile Neutropenia | All Cycles - 2 Days duration | 1 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 5 - 1 Day duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 2 Days duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | All Cycles - 0 Days duration | 51 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 2 - 0 Days duration | 51 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 0 Days duration | 51 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 6 - 0 Days duration | 49 participants |
| Neupogen | Incidence of Febrile Neutropenia | All Cycles - 2 Days duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | All Cycles - 1 Day duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 6 - 1 Day duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 3 - 0 Days duration | 51 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 5 - 0 Days duration | 50 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 1 - 1 Day duration | 0 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 4 - 0 Days duration | 50 participants |
| Neupogen | Incidence of Febrile Neutropenia | Cycle 2 - 1 Day duration | 0 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 4 - 0 Days duration | 202 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 2 - 0 Days duration | 209 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 5 - 0 Days duration | 191 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 1 - 2 Days duration | 1 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 6 - 0 Days duration | 188 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 1 - 1 Day duration | 5 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 6 - 1 Day duration | 2 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 1 - 0 Days duration | 204 participants |
| Total | Incidence of Febrile Neutropenia | All Cycles - 2 Days duration | 1 participants |
| Total | Incidence of Febrile Neutropenia | All Cycles - 0 Days duration | 200 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 5 - 1 Day duration | 1 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 3 - 0 Days duration | 207 participants |
| Total | Incidence of Febrile Neutropenia | Cycle 2 - 1 Day duration | 1 participants |
| Total | Incidence of Febrile Neutropenia | All Cycles - 1 Day duration | 9 participants |
Secondary
Incidence of Hospitalizations Due to Febrile Neutropenia
Incidence of hospitalizations due to Febrile Neutropenia
Time frame: 21 Weeks/ 6 cycles
Population: SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Incidence of Hospitalizations Due to Febrile Neutropenia | No | 50 participants |
| EP2006 + EP2006 & Neupogen | Incidence of Hospitalizations Due to Febrile Neutropenia | Yes | 2 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Hospitalizations Due to Febrile Neutropenia | No | 50 participants |
| Neupogen + Neupogen & EP2006 | Incidence of Hospitalizations Due to Febrile Neutropenia | Yes | 1 participants |
| Neupogen + EP2006 | Incidence of Hospitalizations Due to Febrile Neutropenia | No | 55 participants |
| Neupogen + EP2006 | Incidence of Hospitalizations Due to Febrile Neutropenia | Yes | 0 participants |
| Neupogen | Incidence of Hospitalizations Due to Febrile Neutropenia | Yes | 1 participants |
| Neupogen | Incidence of Hospitalizations Due to Febrile Neutropenia | No | 51 participants |
| Total | Incidence of Hospitalizations Due to Febrile Neutropenia | No | 206 participants |
| Total | Incidence of Hospitalizations Due to Febrile Neutropenia | Yes | 4 participants |
Secondary
Number of Days of Fever
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
Time frame: 21 weeks/ 6 cycles
Population: PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 2 - Yes | 4 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 4 - Yes | 0 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 3 - No | 40 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 3 - Yes | 0 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 1 - No | 39 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 6 - No | 39 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 1 - Yes | 1 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 6 - Yes | 1 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 5 - Yes | 0 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 2 - No | 36 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 4 - No | 40 participants |
| EP2006 + EP2006 & Neupogen | Number of Days of Fever | Cycle 5 - No | 40 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 6 - No | 44 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 2 - Yes | 2 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 4 - No | 44 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 4 - Yes | 1 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 5 - Yes | 1 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 2 - No | 43 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 3 - No | 44 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 3 - Yes | 1 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 1 - Yes | 4 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 5 - No | 44 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 1 - No | 41 participants |
| Neupogen + Neupogen & EP2006 | Number of Days of Fever | Cycle 6 - Yes | 1 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 6 - No | 44 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 3 - Yes | 0 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 4 - No | 43 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 1 - No | 42 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 1 - Yes | 2 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 2 - No | 44 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 2 - Yes | 0 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 3 - No | 44 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 4 - Yes | 1 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 5 - No | 43 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 5 - Yes | 1 participants |
| Neupogen + EP2006 | Number of Days of Fever | Cycle 6 - Yes | 0 participants |
| Neupogen | Number of Days of Fever | Cycle 2 - Yes | 0 participants |
| Neupogen | Number of Days of Fever | Cycle 3 - Yes | 1 participants |
| Neupogen | Number of Days of Fever | Cycle 4 - Yes | 0 participants |
| Neupogen | Number of Days of Fever | Cycle 2 - No | 46 participants |
| Neupogen | Number of Days of Fever | Cycle 5 - No | 45 participants |
| Neupogen | Number of Days of Fever | Cycle 1 - Yes | 0 participants |
| Neupogen | Number of Days of Fever | Cycle 6 - Yes | 0 participants |
| Neupogen | Number of Days of Fever | Cycle 5 - Yes | 1 participants |
| Neupogen | Number of Days of Fever | Cycle 1 - No | 46 participants |
| Neupogen | Number of Days of Fever | Cycle 4 - No | 46 participants |
| Neupogen | Number of Days of Fever | Cycle 6 - No | 46 participants |
| Neupogen | Number of Days of Fever | Cycle 3 - No | 45 participants |
| Total | Number of Days of Fever | Cycle 3 - Yes | 2 participants |
| Total | Number of Days of Fever | Cycle 5 - Yes | 3 participants |
| Total | Number of Days of Fever | Cycle 1 - No | 168 participants |
| Total | Number of Days of Fever | Cycle 4 - Yes | 2 participants |
| Total | Number of Days of Fever | Cycle 2 - No | 169 participants |
| Total | Number of Days of Fever | Cycle 2 - Yes | 6 participants |
| Total | Number of Days of Fever | Cycle 6 - Yes | 2 participants |
| Total | Number of Days of Fever | Cycle 3 - No | 173 participants |
| Total | Number of Days of Fever | Cycle 5 - No | 172 participants |
| Total | Number of Days of Fever | Cycle 1 - Yes | 7 participants |
| Total | Number of Days of Fever | Cycle 4 - No | 173 participants |
| Total | Number of Days of Fever | Cycle 6 - No | 173 participants |
Secondary
Time to Absolute Neutrophil Count Recovery
Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2\*10\^9 cells/L after the nadir in cycle 1
Time frame: Cycle 1/ 21 days
Population: FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 \& Neupogen group, one patient's time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EP2006 + EP2006 & Neupogen | Time to Absolute Neutrophil Count Recovery | 2.0 Days |
| Neupogen + Neupogen & EP2006 | Time to Absolute Neutrophil Count Recovery | 2.0 Days |
| Neupogen + EP2006 | Time to Absolute Neutrophil Count Recovery | 2.0 Days |