Trial Outcomes & Findings for Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients (NCT NCT02104830)
NCT ID: NCT02104830
Last Updated: 2016-10-24
Results Overview
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
3 weeks
Results posted on
2016-10-24
Participant Flow
7 patients were withdrawn for various reasons without receiving any dose of any of the studied products.
Participant milestones
| Measure |
Empegfilgrastim 6 mg
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
43
|
|
Overall Study
COMPLETED
|
38
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.
Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
|
Filgrastim
n=43 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
48.38 years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
50.42 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
51.86 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
50.23 years
STANDARD_DEVIATION 10.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
42 participants
n=5 Participants
|
43 participants
n=7 Participants
|
43 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Histologic type
Infiltrative ductal
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
33 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Histologic type
Infiltrative lobular
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Histologic type
Medullar
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Histologic type
Squamous cell cancer
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Histologic type
Infiltrative not specified
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Histologic type
Low-grade differentiated carcinoma
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Histologic type
Undifferentiated cancer
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Disease stage
IIA
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Disease stage
IIB
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Disease stage
IIIA
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Disease stage
IIIB
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Disease stage
IIIС
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Disease stage
IV
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Adjuvant chemotherapy
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Neoadjuvant chemotherapy
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Radiotherapy
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Hormone therapy
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Surgery treatment
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
22 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
History previous therapy of breast cancer
Any treatment
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
26 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Duration of a disease
|
16.14 months
n=5 Participants
|
11.62 months
n=7 Participants
|
5.37 months
n=5 Participants
|
11.0 months
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Duration of Neutropenia CTCAE Grade 4
|
0.905 days
Standard Deviation 1.206
|
0.791 days
Standard Deviation 1.013
|
1.725 days
Standard Deviation 1.519
|
SECONDARY outcome
Timeframe: 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)Population: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
2nd cycle (week 6)
|
0.452 days
Standard Deviation 1.194
|
0.326 days
Standard Deviation 0.919
|
0.925 days
Standard Deviation 1.385
|
|
The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
3rd cycle (week 9)
|
0.244 days
Standard Deviation 0.734
|
0.310 days
Standard Deviation 0.680
|
0.641 days
Standard Deviation 0.932
|
|
The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);
4th cycle (week 12)
|
0.195 days
Standard Deviation 0.601
|
0.475 days
Standard Deviation 1.320
|
0.892 days
Standard Deviation 1.197
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
The Incidence of Severe Neutropenia (Grade 3-4)
|
40 participants
|
34 participants
|
40 participants
|
SECONDARY outcome
Timeframe: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)Population: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Low Level (Nadir) ANC x 10^9/L
1st cycle (week 3)
|
0.68 cells x 10^9/L
Standard Deviation 0.68
|
0.91 cells x 10^9/L
Standard Deviation 1.11
|
0.47 cells x 10^9/L
Standard Deviation 0.74
|
|
Low Level (Nadir) ANC x 10^9/L
2nd cycle (week 6)
|
1.44 cells x 10^9/L
Standard Deviation 1.30
|
2.10 cells x 10^9/L
Standard Deviation 1.78
|
0.87 cells x 10^9/L
Standard Deviation 1.12
|
|
Low Level (Nadir) ANC x 10^9/L
3rd cycle (week 9)
|
1.77 cells x 10^9/L
Standard Deviation 1.39
|
1.88 cells x 10^9/L
Standard Deviation 1.71
|
0.94 cells x 10^9/L
Standard Deviation 1.04
|
|
Low Level (Nadir) ANC x 10^9/L
4th cycle (week 12)
|
1.67 cells x 10^9/L
Standard Deviation 1.12
|
2.07 cells x 10^9/L
Standard Deviation 1.75
|
0.75 cells x 10^9/L
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)Population: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Neutropenia Duration, Any Grade
1st cycle (week 3)
|
2.214 days
Standard Deviation 1.152
|
1.953 days
Standard Deviation 1.194
|
4.0 days
Standard Deviation 3.121
|
|
Neutropenia Duration, Any Grade
2nd cycle (week 6)
|
1.881 days
Standard Deviation 2.276
|
1.233 days
Standard Deviation 1.702
|
2.775 days
Standard Deviation 2.434
|
|
Neutropenia Duration, Any Grade
3rd cycle (week 9)
|
1.585 days
Standard Deviation 1.897
|
1.024 days
Standard Deviation 1.199
|
2.487 days
Standard Deviation 2.480
|
|
Neutropenia Duration, Any Grade
4th cycle (week 12)
|
1.146 days
Standard Deviation 1.195
|
1.525 days
Standard Deviation 2.364
|
2.919 days
Standard Deviation 2.488
|
SECONDARY outcome
Timeframe: 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)Population: The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.
Outcome measures
| Measure |
Empegfilgrastim 6 mg
n=42 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=40 Participants
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
1st cycle (week 3)
|
1.74 days
Standard Deviation 0.98
|
1.51 days
Standard Deviation 0.86
|
2.98 days
Standard Deviation 2.40
|
|
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
2nd cycle (week 6)
|
1.43 days
Standard Deviation 1.29
|
1.05 days
Standard Deviation 1.31
|
2.05 days
Standard Deviation 1.08
|
|
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
3rd cycle (week 9)
|
1.20 days
Standard Deviation 1.21
|
0.98 days
Standard Deviation 0.90
|
1.90 days
Standard Deviation 1.87
|
|
Duration From ANC Nadir to ANC < 2.0 x 10^9/L
4th cycle (week 12)
|
1.12 days
Standard Deviation 1.05
|
1.03 days
Standard Deviation 1.20
|
2.14 days
Standard Deviation 1.70
|
Adverse Events
Empegfilgrastim 6 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Empegfilgrastim 7.5 mg
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Filgrastim
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empegfilgrastim 6 mg
n=42 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=43 participants at risk
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Uterine bleeding
|
2.4%
1/42 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Musculoskeletal and connective tissue disorders
Left hand fracture
|
0.00%
0/42 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Infections and infestations
nose furunculus 3 grade
|
0.00%
0/42 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/42 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/42 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
Other adverse events
| Measure |
Empegfilgrastim 6 mg
n=42 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Empegfilgrastim 7.5 mg
n=43 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy
Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
|
Filgrastim
n=43 participants at risk
Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
neutropenia any grade
|
97.6%
41/42 • Number of events 41 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
86.0%
37/43 • Number of events 37 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
95.3%
41/43 • Number of events 41 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Blood and lymphatic system disorders
Anemia
|
40.5%
17/42 • Number of events 17 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
30.2%
13/43 • Number of events 13 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
44.2%
19/43 • Number of events 19 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Blood and lymphatic system disorders
Leucopenia
|
97.6%
41/42 • Number of events 41 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
88.4%
38/43 • Number of events 38 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
95.3%
41/43 • Number of events 41 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/42 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
7.0%
3/43 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Endocrine disorders
Hyperglycemia
|
14.3%
6/42 • Number of events 6 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
18.6%
8/43 • Number of events 8 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
20.9%
9/43 • Number of events 9 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
16.7%
7/42 • Number of events 7 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
16.3%
7/43 • Number of events 7 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Hepatobiliary disorders
Liver enzymes (ALT) elevation
|
9.5%
4/42 • Number of events 4 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Injury, poisoning and procedural complications
Hyperemia after injection
|
7.1%
3/42 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
0.00%
0/43 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
General disorders
Weakness / asthenia
|
61.9%
26/42 • Number of events 26 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
55.8%
24/43 • Number of events 24 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
55.8%
24/43 • Number of events 24 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
General disorders
Fever
|
4.8%
2/42 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
7.0%
3/43 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.5%
4/42 • Number of events 4 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
9.3%
4/43 • Number of events 4 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
3/42 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
6/42 • Number of events 6 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
7.0%
3/43 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
7.0%
3/43 • Number of events 3 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
|
General disorders
Headache
|
2.4%
1/42 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
2.3%
1/43 • Number of events 1 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
4.7%
2/43 • Number of events 2 • 3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place