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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-627 | Experimental | F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy |
|
| GRAN® | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-627 | Drug | Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2 |
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Inclusion Criteria:
Exclusion Criteria:
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;
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Shao, Doctor | Fudan University Shanghai Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39272058 | Derived | Zhang Q, Wang Z, Yao W, Wang S, Zhang G, Chen J, Hou Q, Li S, Li H, Ye C, Sun T, Yang H, Chen Z, Wang Z, Liu X, Geng C, Li X, Zhang J, Zheng H, Shao Z. A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer. BMC Cancer. 2024 Sep 13;24(1):1143. doi: 10.1186/s12885-024-12892-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 F-627: Single dose pre-filled syringe |
| FG001 | GRAN® | Recombinant Human Granulocyte Colony Stimulating Factor (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 GRAN®: Multi-dose pre-filled syringe |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The started participants were all the subjects randomized, but the baseline participants were those randomized subjects received one study drugs at least.
A total of 242 subjects were enrolled and randomized. Only 239 randomized patients received one study drugs at least, and included in the full analysis set (FAS), which were consisted of the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All subjects who have completed cycle 1 | Posted | Mean | Standard Deviation | days | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catrina Wang | Evivebiotech | 021-61760866 | catrina.wang@evivebiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2018 | Sep 12, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2019 | Sep 12, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| GRAN® | Drug | 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®) |
|
|
Grade 3 defined as ANC <1.0×10^9/L and Grade 4 defined as ANC<0.5×10^9/L |
| Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Number of Participants With Grade 4 Neutropenia in Cycle 1 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Number of Participants With Grade 4 Neutropenia in Cycle 2 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Number of Participants With Grade 4 Neutropenia in Cycle 3 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| Number of Participants With Grade 4 Neutropenia in Cycle 4 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Overall 4, 21-day chemotherapy cycles(average 12 weeks) |
| 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 | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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). | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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 | From day 3 to day 13 of cycle 1 (11 days) |
| 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). | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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. | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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. | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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. | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
| 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. | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | m |
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| Weight | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| body surface area (BSA) | Mean | Standard Deviation | m^2 |
|
F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy
| OG001 | 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 |
|
|
| 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 | All subjects who have completed cycle 1 | Posted | Count of Participants | Participants | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
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| 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 | All subjects who have completed cycle 2 | Posted | Count of Participants | Participants | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
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| 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 | All subjects who have completed cycle 3 | Posted | Count of Participants | Participants | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
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| 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 | All subjects who have completed cycle 4 | Posted | Count of Participants | Participants | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
|
| 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). | All subjects who have completed cycle 2 | Posted | Mean | Standard Deviation | days | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 3 | Posted | Mean | Standard Deviation | days | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 4 | Posted | Mean | Standard Deviation | days | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
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| Secondary | Number of Participants With Grade 4 Neutropenia in Cycle 1 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | All subjects who have completed cycle 1 | Posted | Count of Participants | Participants | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
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| Secondary | Number of Participants With Grade 4 Neutropenia in Cycle 2 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | All subjects who have completed cycle 2 | Posted | Count of Participants | Participants | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
|
|
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| Secondary | Number of Participants With Grade 4 Neutropenia in Cycle 3 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | All subjects who have completed cycle 3 | Posted | Count of Participants | Participants | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| Secondary | Number of Participants With Grade 4 Neutropenia in Cycle 4 | Grade 4 neutropenia is defined as ANC < 0.5 × 10^9/L. | All subjects who have completed cycle 4 | Posted | Count of Participants | Participants | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 1 | Posted | Mean | Standard Deviation | days | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 2 | Posted | Mean | Standard Deviation | days | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 3 | Posted | Mean | Standard Deviation | days | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 4 | Posted | Mean | Standard Deviation | days | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 1 at least. | Posted | Mean | Standard Deviation | days | Overall 4, 21-day chemotherapy cycles(average 12 weeks) |
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| 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 | All subjects who have completed cycle 1. | Posted | Count of Participants | Participants | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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 | All subjects who have completed cycle 2. | Posted | Count of Participants | Participants | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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 | All subjects who have completed cycle 3. | Posted | Count of Participants | Participants | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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 | All subjects who have completed cycle 4. | Posted | Count of Participants | Participants | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 1. | Posted | Mean | Standard Deviation | days | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 2 | Posted | Mean | Standard Deviation | days | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 3. | Posted | Mean | Standard Deviation | days | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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). | All subjects who have completed cycle 4. | Posted | Mean | Standard Deviation | days | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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 | All subjects who have completed cycle 1 | Posted | Mean | Standard Deviation | 10^9 cell/L | From day 3 to day 13 of cycle 1 (11 days) |
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| 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). | All subjects who have completed cycle 1 | Posted | Count of Participants | Participants | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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. | All subjects who have completed cycle 1 | Posted | Mean | Standard Deviation | days | Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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. | All subjects who have completed cycle 2 | Posted | Mean | Standard Deviation | days | Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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. | All subjects who have completed cycle 3 | Posted | Mean | Standard Deviation | days | Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 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. | All subjects who have completed cycle 4 | Posted | Mean | Standard Deviation | days | Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks) |
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| 0 |
| 120 |
| 6 |
| 120 |
| 119 |
| 120 |
| EG001 | 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 | 0 | 119 | 8 | 119 | 119 | 119 |
| Platelet count decreased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Jugular vein thrombosis | Vascular disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |