Trial Outcomes & Findings for Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm (NCT NCT02043301)
NCT ID: NCT02043301
Last Updated: 2019-05-31
Results Overview
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Results posted on
2019-05-31
Participant Flow
Seventy-five (75) participants were enrolled and randomized in a 1:1:1 ratio to receive a single dose of Treatment A (PF-04950615 \[hereafter referred to as bococizumab\] 150 mg subcutaneously \[SC\] to the abdomen), Treatment B (bococizumab 150 mg SC to the thigh), or Treatment C (bococizumab 150 mg SC to the upper arm).
Participant milestones
| Measure |
Bococizumab 150 mg Abdomen
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Bococizumab 150 mg Abdomen
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Overall Study
Discontinued
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
Baseline characteristics by cohort
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less than (<) 18 years
|
0 Participants
11.7 • n=5 Participants
|
0 Participants
7.5 • n=7 Participants
|
0 Participants
9.6 • n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18-44 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Customized
45-64 years
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
|
175.9 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 53
|
198.9 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 30
|
160.3 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.
Maximum observed concentration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
9.68 mcg/mL
Geometric Coefficient of Variation 51
|
11.89 mcg/mL
Geometric Coefficient of Variation 30
|
8.14 mcg/mL
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.
AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
|
158.8 mcg*day/mL
Geometric Coefficient of Variation 65
|
192.5 mcg*day/mL
Geometric Coefficient of Variation 31
|
152.6 mcg*day/mL
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.
Time for maximum observed concentration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.04 days
Interval 2.0 to 7.02
|
4.25 days
Interval 2.92 to 6.97
|
6.93 days
Interval 2.0 to 14.1
|
SECONDARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Apparent clearance following subcutaneous administration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Apparent Clearance (CL/F)
|
0.8521 liters per day
Geometric Coefficient of Variation 53
|
0.7545 liters per day
Geometric Coefficient of Variation 30
|
0.9352 liters per day
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Apparent volume of distribution following subcutaneous administration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
8.84 liters
Geometric Coefficient of Variation 49
|
7.98 liters
Geometric Coefficient of Variation 29
|
11.33 liters
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.Population: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Terminal elimination half-life following subcutaneous administration.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2)
|
7.27 days
Standard Deviation 1.09
|
7.40 days
Standard Deviation 1.03
|
8.53 days
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.
Maximum LDL-C response using absolute on trial LDL-C data
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Maximum Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value
|
72.20 mg/dL
Standard Deviation 20.185
|
75.32 mg/dL
Standard Deviation 31.964
|
74.40 mg/dL
Standard Deviation 25.290
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.
LDL-C Emax expressed as change from baseline.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Emax: Change From Baseline
|
-96.88 mg/dL
Standard Deviation 19.356
|
-97.62 mg/dL
Standard Deviation 26.967
|
-90.46 mg/dL
Standard Deviation 25.441
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.
LDL-C Emax expressed as percent change from baseline.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Emax: Percent Change From Baseline
|
-57.47 percent change
Standard Deviation 9.084
|
-56.98 percent change
Standard Deviation 14.740
|
-54.96 percent change
Standard Deviation 13.269
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.
Time to LDL-C Emax
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Time to Reach Maximum LDL-C Lowering (Tmax, LDL-C)
|
20.96 days
Full Range 7.461 • Interval 5.0 to 34.1
|
20.06 days
Full Range 5.173 • Interval 4.2 to 28.0
|
14.01 days
Full Range 7.102 • Interval 7.1 to 42.0
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Area Under the LDL-C Effect Curve (AUEC): Absolute Value
|
11181.64 mg*day/dL
Standard Deviation 1545.335
|
11682.39 mg*day/dL
Standard Deviation 2063.772
|
11231.39 mg*day/dL
Standard Deviation 1928.904
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
AUEC: Change From Baseline
|
-2982.16 mg*day/dL
Standard Deviation 1431.589
|
-2701.99 mg*day/dL
Standard Deviation 1432.539
|
-2546.68 mg*day/dL
Standard Deviation 977.934
|
SECONDARY outcome
Timeframe: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early TerminationPopulation: The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=24 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
AUEC: Percent Change From Baseline
|
-1715.22 percent change
Standard Deviation 758.720
|
-1538.85 percent change
Standard Deviation 724.925
|
-1550.73 percent change
Standard Deviation 583.745
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: The safety analysis population included all participants who received at least 1 dose of study medication.
Acute injection site reactions (e.g, pain, pruritus, induration) were captured as adverse events (AEs). Intensity of the AE was described as mild (does not interfere with usual function), moderate (interferes to some extent with usual function), or severe (interferes significantly with participant's usual function).
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site erythema
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site indurations
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site pain
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site pruritus
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site reaction
|
1 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Mild: injection site swelling
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site erythema
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site indurations
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site pruritus
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site reaction
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Moderate: injection site swelling
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site erythema
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site indurations
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site pruritus
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site reaction
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Injection Site Reactions (ISRs) by Severity
Severe: injection site swelling
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, Day 57 and Day 85/Early TerminationPopulation: The safety analysis population included all participants who received at least 1 dose of study medication.
A participant is ADA positive if ADA titer (log2) \>=6.23. A participant is nAb positive if nAb titer (log2) \>=4.32.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Positive ADA
|
6 participants
|
6 participants
|
11 participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Positive nAb
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, Day 57 and Day 85/Early TerminationPopulation: The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for titer.
ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Anti-Drug Antibody (ADA) Titer
Day 15
|
NA Log2 titer
Interval 13.65 to 13.65
Only 1 participant has reportable data, median value is not applicable.
|
NA Log2 titer
Interval 7.91 to 7.91
Only 1 participant has reportable data, median value is not applicable.
|
—
|
|
Anti-Drug Antibody (ADA) Titer
Day 29
|
NA Log2 titer
Interval 12.49 to 12.49
Only 1 participant has reportable data, median value is not applicable.
|
NA Log2 titer
Interval 6.23 to 7.39
Only 2 participants have reportable data, median value is not applicable.
|
—
|
|
Anti-Drug Antibody (ADA) Titer
Day 57
|
NA Log2 titer
Interval 13.22 to 13.22
Only 1 participant has reportable data, median value is not applicable.
|
7.64 Log2 titer
Interval 7.61 to 10.84
|
8.25 Log2 titer
Interval 6.35 to 9.28
|
|
Anti-Drug Antibody (ADA) Titer
Day 85
|
7.46 Log2 titer
Interval 6.31 to 13.57
|
7.20 Log2 titer
Interval 6.23 to 15.05
|
7.60 Log2 titer
Interval 6.23 to 13.01
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, Day 57 and Day 85/Early TerminationPopulation: The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for nAb. nAb titer was determined if a sample is screened positive for nAb. nAb titer data for the Bococizumab 150 mg Upper Arm group is not presented as there were no nAb positive subjects.
nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Outcome measures
| Measure |
Bococizumab 150 mg Abdomen
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 Participants
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Neutralizing Antibody (nAb) Titer
Day 29
|
NA Log2 titer
Interval 6.24 to 6.24
Only 1 participant has reportable data, median value is not applicable.
|
—
|
—
|
|
Neutralizing Antibody (nAb) Titer
Day 57
|
NA Log2 titer
Interval 5.93 to 5.93
Only 1 participant has reportable data, median value is not applicable.
|
NA Log2 titer
Interval 4.94 to 4.94
Only 1 participant has reportable data, median value is not applicable.
|
—
|
|
Neutralizing Antibody (nAb) Titer
Day 85
|
NA Log2 titer
Interval 4.4 to 6.03
Only 2 participants have reportable data, median value is not applicable.
|
NA Log2 titer
Interval 4.32 to 7.35
Only 2 participants have reportable data, median value is not applicable.
|
—
|
Adverse Events
Bococizumab 150 mg Abdomen
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Bococizumab 150 mg Thigh
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Bococizumab 150 mg Upper Arm
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bococizumab 150 mg Abdomen
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Bococizumab 150 mg Abdomen
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the abdomen.
|
Bococizumab 150 mg Thigh
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the thigh.
|
Bococizumab 150 mg Upper Arm
n=25 participants at risk
Participants received a single dose of bococizumab 150 mg SC to the upper arm.
|
|---|---|---|---|
|
Eye disorders
Noninfective conjunctivitis
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site erythema
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site induration
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site pain
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site pruritus
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site reaction
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.0%
3/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site swelling
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Therapeutic response changed
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infected dermal cyst
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.0%
4/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
4.0%
1/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/25 • Baseline up to Day 85
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER