Breast Cancer, Neutropenia
Conditions
Brief summary
A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia
Detailed description
Study Stage: Phase III Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2. Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial
Interventions
DRUGF-627
Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy
DRUGGRAN®
Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)
Sponsors
EVIVE Biotechnology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to sign the informed consent form and able to comply with protocol requirements; 2. 18-75 years old; 3. Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m\^2 + cyclophosphamide 600 mg/m\^2; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 5. Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 11.0 g/dL, and platelet (PLT) ≥ 100 × 10\^9/L prior to enrollment; 6. Hepatic and renal functions: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN; 7. Left ventricular ejection fraction \> 50%; 8. Women without child-bearing potential, i.e., women who have had menopause for at least 1 year or who have undergone sterilization (bilateral tubal ligation, double oophorectomy or hysterectomy); patients with child-bearing potential should agree to take appropriate contraceptive measures, including condoms, spermicidal condoms, foams, gels, contraceptive barrier, intrauterine devices (IUD), and contraceptives (oral or injection), starting from 1 month before the start of the study until 30 days after the end of the study.
Exclusion criteria
1. Radiation therapy within 4 weeks prior to enrollment; 2. Patients with breast cancer who have received neoadjuvant chemotherapy before surgery; 3. Prior bone marrow or stem cell transplant; 4. With other malignant tumors other than breast cancer; 5. Patients who have received a treatment with recombinant human granulocyte colony stimulating factor within 6 weeks prior to randomization; 6. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, ECG or other approaches; 7. With any disease that may cause splenomegaly; 8. With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C; 9. Women in pregnancy or breastfeeding; 10. Known HIV positive or AIDS; 11. With active tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray; 12. With sickle cell anemia; 13. With alcohol or drug abuse that may affect the compliance with the study; 14. With known hypersensitivity to granulocyte colony stimulating factor or excipients; 15. Have received any other investigational drug within 1 month or 5 half-lives of the investigational drugs prior to enrollment (whichever is longer); 16. Patients with diseases or symptoms unsuitable for participating in the trial. For example, the study drugs may compromise the health of the patient or the assessment of adverse events may be affected.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L |
| Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L |
| Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L |
| Duration of Grade 3 or 4 Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration of Grade 3 or 4 Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration of Grade 3 or 4 Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Number of Participants With Grade 4 Neutropenia in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. |
| Number of Participants With Grade 4 Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. |
| Number of Participants With Grade 4 Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. |
| Number of Participants With Grade 4 Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. |
| Duration of Grade 4 Neutropenia in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration of Grade 4 Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration of Grade 4 Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration of Grade 4 Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L |
| Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L |
| Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L |
| Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L |
| Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L |
| Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
| The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1 | From day 3 to day 13 of cycle 1 (11 days) | The minimum value of ANC measured from day 3 to day 13 of cycle 1 |
| Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | FN is defined as ANC \< 1.0 × 10\^9/L with fever (a single measurement of body temperature \>38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr). |
| Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) | If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days. |
| Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) | If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days. |
| Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) | If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days. |
| Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) | If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days. |
| Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles | Overall 4, 21-day chemotherapy cycles(average 12 weeks) | Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F-627 F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy | 120 |
| GRAN® GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy | 119 |
| Total | 239 |
Baseline characteristics
| Characteristic | GRAN® | F-627 | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 9.14 | 49.1 years STANDARD_DEVIATION 9.32 | 48.8 years STANDARD_DEVIATION 9.21 |
| Body mass index (BMI) | 23.782 kg/m^2 STANDARD_DEVIATION 3.336 | 23.609 kg/m^2 STANDARD_DEVIATION 3.278 | 23.695 kg/m^2 STANDARD_DEVIATION 3.301 |
| body surface area (BSA) | 1.594 m^2 STANDARD_DEVIATION 0.116 | 1.591 m^2 STANDARD_DEVIATION 0.123 | 1.593 m^2 STANDARD_DEVIATION 0.119 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 120 Participants | 239 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 157.87 m STANDARD_DEVIATION 5.524 | 157.97 m STANDARD_DEVIATION 5.061 | 157.92 m STANDARD_DEVIATION 5.286 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 119 Participants | 120 Participants | 239 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 119 participants | 120 participants | 239 participants |
| Sex: Female, Male Female | 119 Participants | 120 Participants | 239 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 59.24 kg STANDARD_DEVIATION 8.487 | 58.96 kg STANDARD_DEVIATION 8.945 | 59.10 kg STANDARD_DEVIATION 8.703 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 119 |
| other Total, other adverse events | 119 / 120 | 119 / 119 |
| serious Total, serious adverse events | 6 / 120 | 8 / 119 |
Outcome results
Primary
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1 | 0.68 days | Standard Deviation 1.1 |
| GRAN® | Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1 | 0.71 days | Standard Deviation 0.967 |
Secondary
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1 | 1.1 days | Standard Deviation 1.3 |
| GRAN® | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1 | 1.0 days | Standard Deviation 1.1 |
Secondary
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2 | 0.2 days | Standard Deviation 0.5 |
| GRAN® | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2 | 0.2 days | Standard Deviation 0.5 |
Secondary
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3 | 0.1 days | Standard Deviation 0.42 |
| GRAN® | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3 | 0.4 days | Standard Deviation 0.67 |
Secondary
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4 | 0.3 days | Standard Deviation 0.68 |
| GRAN® | Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4 | 0.3 days | Standard Deviation 0.63 |
Secondary
Duration of Grade 3 or 4 Neutropenia in Cycle 2
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 3 or 4 Neutropenia in Cycle 2 | 0.1 days | Standard Deviation 0.35 |
| GRAN® | Duration of Grade 3 or 4 Neutropenia in Cycle 2 | 0.1 days | Standard Deviation 0.25 |
Secondary
Duration of Grade 3 or 4 Neutropenia in Cycle 3
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 3 or 4 Neutropenia in Cycle 3 | 0.0 days | Standard Deviation 0.18 |
| GRAN® | Duration of Grade 3 or 4 Neutropenia in Cycle 3 | 0.2 days | Standard Deviation 0.54 |
Secondary
Duration of Grade 3 or 4 Neutropenia in Cycle 4
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 3 or 4 Neutropenia in Cycle 4 | 0.1 days | Standard Deviation 0.38 |
| GRAN® | Duration of Grade 3 or 4 Neutropenia in Cycle 4 | 0.1 days | Standard Deviation 0.41 |
Secondary
Duration of Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 4 Neutropenia in Cycle 1 | 0.3 days | Standard Deviation 0.69 |
| GRAN® | Duration of Grade 4 Neutropenia in Cycle 1 | 0.2 days | Standard Deviation 0.58 |
Secondary
Duration of Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 4 Neutropenia in Cycle 2 | 0.0 days | Standard Deviation 0.13 |
| GRAN® | Duration of Grade 4 Neutropenia in Cycle 2 | 0.0 days | Standard Deviation 0.1 |
Secondary
Duration of Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 4 Neutropenia in Cycle 3 | 0.0 days | Standard Deviation 0 |
| GRAN® | Duration of Grade 4 Neutropenia in Cycle 3 | 0.1 days | Standard Deviation 0.34 |
Secondary
Duration of Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Duration of Grade 4 Neutropenia in Cycle 4 | 0.0 days | Standard Deviation 0.13 |
| GRAN® | Duration of Grade 4 Neutropenia in Cycle 4 | 0.0 days | Standard Deviation 0.2 |
Secondary
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN is defined as ANC \< 1.0 × 10\^9/L with fever (a single measurement of body temperature \>38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | 1 Participants |
| GRAN® | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 | 2 Participants |
Secondary
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1 | 58 Participants |
| GRAN® | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1 | 67 Participants |
Secondary
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2 | 16 Participants |
| GRAN® | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2 | 14 Participants |
Secondary
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3 | 14 Participants |
| GRAN® | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3 | 30 Participants |
Secondary
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4 | 20 Participants |
| GRAN® | Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4 | 26 Participants |
Secondary
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1 | 41 Participants |
| GRAN® | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1 | 51 Participants |
Secondary
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2 | 7 Participants |
| GRAN® | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2 | 7 Participants |
Secondary
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3 | 4 Participants |
| GRAN® | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3 | 18 Participants |
Secondary
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4 | 10 Participants |
| GRAN® | Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4 | 10 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia in Cycle 1
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 4 Neutropenia in Cycle 1 | 17 Participants |
| GRAN® | Number of Participants With Grade 4 Neutropenia in Cycle 1 | 19 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia in Cycle 2
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 4 Neutropenia in Cycle 2 | 2 Participants |
| GRAN® | Number of Participants With Grade 4 Neutropenia in Cycle 2 | 1 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia in Cycle 3
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 4 Neutropenia in Cycle 3 | 0 Participants |
| GRAN® | Number of Participants With Grade 4 Neutropenia in Cycle 3 | 4 Participants |
Secondary
Number of Participants With Grade 4 Neutropenia in Cycle 4
Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| F-627 | Number of Participants With Grade 4 Neutropenia in Cycle 4 | 2 Participants |
| GRAN® | Number of Participants With Grade 4 Neutropenia in Cycle 4 | 4 Participants |
Secondary
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L According to the study protocol, the outcome measure Duration of Grade 3 or 4 Neutropenia (days) applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).
Time frame: Overall 4, 21-day chemotherapy cycles(average 12 weeks)
Population: All subjects who have completed cycle 1 at least.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles | 0.9 days | Standard Deviation 1.44 |
| GRAN® | Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles | 1.1 days | Standard Deviation 1.43 |
Secondary
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
The minimum value of ANC measured from day 3 to day 13 of cycle 1
Time frame: From day 3 to day 13 of cycle 1 (11 days)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1 | 2.058 10^9 cell/L | Standard Deviation 1.503 |
| GRAN® | The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1 | 1.597 10^9 cell/L | Standard Deviation 1.197 |
Secondary
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1 | 0.9 days | Standard Deviation 1.01 |
| GRAN® | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1 | 1.0 days | Standard Deviation 0.84 |
Secondary
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2 | 0.5 days | Standard Deviation 1.1 |
| GRAN® | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2 | 0.7 days | Standard Deviation 0.99 |
Secondary
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3 | 0.4 days | Standard Deviation 0.87 |
| GRAN® | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3 | 0.9 days | Standard Deviation 1.5 |
Secondary
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.
Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Population: All subjects who have completed cycle 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| F-627 | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4 | 0.7 days | Standard Deviation 1.14 |
| GRAN® | Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4 | 1.2 days | Standard Deviation 1.73 |