Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers (NCT NCT02506881)
NCT ID: NCT02506881
Last Updated: 2016-06-14
Results Overview
Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
336 hours (sc) / 72 hours (iv)
Results posted on
2016-06-14
Participant Flow
Participant milestones
| Measure |
BCD-066 → Aranesp - Subcutaneous
Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
Aranesp → BCD-066 - Subcutaneous
Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
BCD-066 → Aranesp - Intravenous
Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
Aranesp → BCD-066 - Intravenous
Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
|---|---|---|---|---|
|
First Intervention (Day 1)
STARTED
|
13
|
12
|
25
|
24
|
|
First Intervention (Day 1)
COMPLETED
|
12
|
12
|
12
|
12
|
|
First Intervention (Day 1)
NOT COMPLETED
|
1
|
0
|
13
|
12
|
|
Washout (at Least 25 Days)
STARTED
|
12
|
12
|
12
|
12
|
|
Washout (at Least 25 Days)
COMPLETED
|
12
|
12
|
12
|
12
|
|
Washout (at Least 25 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (Day 1)
STARTED
|
12
|
12
|
12
|
12
|
|
Second Intervention (Day 1)
COMPLETED
|
12
|
12
|
12
|
12
|
|
Second Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
BCD-066 → Aranesp - Subcutaneous
Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
Aranesp → BCD-066 - Subcutaneous
Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
BCD-066 → Aranesp - Intravenous
Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
Aranesp → BCD-066 - Intravenous
Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Darbepoetin alfa
|
|---|---|---|---|---|
|
First Intervention (Day 1)
Protocol Violation
|
0
|
0
|
1
|
0
|
|
First Intervention (Day 1)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
First Intervention (Day 1)
Violation of blood storage conditions
|
0
|
0
|
12
|
12
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BCD-066 → Aranesp - Subcutaneous
n=13 Participants
Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
|
Aranesp → BCD-066 - Subcutaneous
n=12 Participants
Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
|
BCD-066 → Aranesp - Intravenous
n=25 Participants
Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
|
Aranesp → BCD-066 - Intravenous
n=24 Participants
Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
74 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
23 years
n=5 Participants
|
22 years
n=7 Participants
|
24 years
n=5 Participants
|
24.5 years
n=4 Participants
|
24 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 336 hours (sc) / 72 hours (iv)Population: Population for pharmacokinetics analysis: patients who received at least one study drug injection.
Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
AUC
|
150607 (pg/ml)*hour
Interval 115435.0 to 185031.0
|
152208 (pg/ml)*hour
Interval 116362.0 to 212041.0
|
504584 (pg/ml)*hour
Interval 463396.0 to 626538.0
|
544818 (pg/ml)*hour
Interval 456106.0 to 606407.0
|
PRIMARY outcome
Timeframe: 336 hours (sc) / 72 hours (iv)Population: Population for pharmacokinetics analysis included patients who received at least one study drug injection.
Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
Cmax
|
984 pg/ml
Interval 789.0 to 1226.0
|
885 pg/ml
Interval 808.0 to 1197.0
|
23908 pg/ml
Interval 21535.0 to 27531.0
|
24478 pg/ml
Interval 22271.0 to 29381.0
|
PRIMARY outcome
Timeframe: 504 hoursPopulation: Population for pharmacokinetics analysis included patients who received at least one study drug injection.
Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
AUEC
|
28248 (reticulocytes * 10^9/l)*hour
Interval 22162.0 to 32648.0
|
27916 (reticulocytes * 10^9/l)*hour
Interval 22827.0 to 32628.0
|
35610 (reticulocytes * 10^9/l)*hour
Interval 29578.0 to 41423.0
|
36928 (reticulocytes * 10^9/l)*hour
Interval 28773.0 to 42247.0
|
PRIMARY outcome
Timeframe: 504 hoursPopulation: Population for analysis of pharmacodynamics included patients who received at least one study drug injection.
Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
AC-Emax
|
44.8 reticulocytes * 10^9/l
Interval 26.8 to 62.3
|
54.55 reticulocytes * 10^9/l
Interval 40.7 to 69.0
|
71.3 reticulocytes * 10^9/l
Interval 51.9 to 85.3
|
72.1 reticulocytes * 10^9/l
Interval 55.5 to 86.7
|
SECONDARY outcome
Timeframe: 336 hours (sc) / 72 hours (iv)Population: Population for pharmacokinetics analysis: patients who received at least one study drug injection.
Serum half-life of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
T1/2
|
74.8 hours
Interval 69.6 to 92.6
|
80.6 hours
Interval 65.7 to 89.9
|
13.1 hours
Interval 12.7 to 13.9
|
12.7 hours
Interval 12.4 to 13.9
|
SECONDARY outcome
Timeframe: 336 hours (sc) / 72 hours (iv)Population: Population for pharmacokinetics analysis: patients who received at least one study drug injection.
Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
Tmax
|
36 hours
Interval 16.0 to 36.0
|
36 hours
Interval 36.0 to 36.0
|
0.25 hours
Interval 0.08 to 0.5
|
0.25 hours
Interval 0.08 to 0.4
|
SECONDARY outcome
Timeframe: 336 hours (sc) / 72 hours (iv)Population: Population for pharmacokinetics analysis: patients who received at least one study drug injection.
Serum clearance of of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.
Outcome measures
| Measure |
BCD-066 Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
Aranesp® Subcutaneous
n=24 Participants
Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 336 hours is reported.
|
BCD-066 - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
Aranesp® - Intravenous
n=23 Participants
Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
AUC of darbepoetin alfa 0 to 72 hours is reported.
|
|---|---|---|---|---|
|
Cl
|
0.433 hours*kg
Interval 0.308 to 0.587
|
0.375 hours*kg
Interval 0.314 to 0.566
|
139.0 hours*kg
Interval 123.9 to 153.7
|
134.2 hours*kg
Interval 114.0 to 159.2
|
Adverse Events
BCD-066 Subcutaneous
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Aranesp® Subcutaneous
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
BCD-066 - Intravenous
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Aranesp® - Intravenous
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCD-066 Subcutaneous
n=25 participants at risk
Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
|
Aranesp® Subcutaneous
n=25 participants at risk
Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
|
BCD-066 - Intravenous
n=49 participants at risk
Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
|
Aranesp® - Intravenous
n=49 participants at risk
Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
4.1%
2/49 • 0 to 504 hours after injection
|
4.1%
2/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Elevated hematocrit
|
4.0%
1/25 • 0 to 504 hours after injection
|
8.0%
2/25 • 0 to 504 hours after injection
|
6.1%
3/49 • 0 to 504 hours after injection
|
8.2%
4/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Elevated reticulocyte count
|
68.0%
17/25 • 0 to 504 hours after injection
|
68.0%
17/25 • 0 to 504 hours after injection
|
83.7%
41/49 • 0 to 504 hours after injection
|
85.7%
42/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Leucopenia
|
20.0%
5/25 • 0 to 504 hours after injection
|
20.0%
5/25 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Leucocytosis
|
36.0%
9/25 • 0 to 504 hours after injection
|
24.0%
6/25 • 0 to 504 hours after injection
|
22.4%
11/49 • 0 to 504 hours after injection
|
34.7%
17/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
5/25 • 0 to 504 hours after injection
|
24.0%
6/25 • 0 to 504 hours after injection
|
14.3%
7/49 • 0 to 504 hours after injection
|
12.2%
6/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Decrease in hematocrit
|
8.0%
2/25 • 0 to 504 hours after injection
|
8.0%
2/25 • 0 to 504 hours after injection
|
12.2%
6/49 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Decrease in reticulocyte count
|
24.0%
6/25 • 0 to 504 hours after injection
|
28.0%
7/25 • 0 to 504 hours after injection
|
18.4%
9/49 • 0 to 504 hours after injection
|
8.2%
4/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
16.0%
4/25 • 0 to 504 hours after injection
|
12.0%
3/25 • 0 to 504 hours after injection
|
12.2%
6/49 • 0 to 504 hours after injection
|
18.4%
9/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Monocytosis
|
40.0%
10/25 • 0 to 504 hours after injection
|
44.0%
11/25 • 0 to 504 hours after injection
|
57.1%
28/49 • 0 to 504 hours after injection
|
38.8%
19/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Elevated neutrophil count
|
8.0%
2/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
12.2%
6/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Elevated basophil count
|
8.0%
2/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
2.0%
1/49 • 0 to 504 hours after injection
|
4.1%
2/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Decreased eosinophil count
|
4.0%
1/25 • 0 to 504 hours after injection
|
8.0%
2/25 • 0 to 504 hours after injection
|
0.00%
0/49 • 0 to 504 hours after injection
|
2.0%
1/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Increased eosinophil count
|
8.0%
2/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
8.2%
4/49 • 0 to 504 hours after injection
|
12.2%
6/49 • 0 to 504 hours after injection
|
|
Renal and urinary disorders
Elevated creatinine
|
8.0%
2/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
14.3%
7/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Erythrocytosis
|
4.0%
1/25 • 0 to 504 hours after injection
|
0.00%
0/25 • 0 to 504 hours after injection
|
24.5%
12/49 • 0 to 504 hours after injection
|
26.5%
13/49 • 0 to 504 hours after injection
|
|
Blood and lymphatic system disorders
Trombocytosis
|
0.00%
0/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
8.2%
4/49 • 0 to 504 hours after injection
|
10.2%
5/49 • 0 to 504 hours after injection
|
|
Hepatobiliary disorders
Elevated ALT
|
4.0%
1/25 • 0 to 504 hours after injection
|
4.0%
1/25 • 0 to 504 hours after injection
|
8.2%
4/49 • 0 to 504 hours after injection
|
4.1%
2/49 • 0 to 504 hours after injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place