Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease (NCT NCT03351738)
NCT ID: NCT03351738
Last Updated: 2020-03-23
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Day 1 (Baseline) through Day 241
Results posted on
2020-03-23
Participant Flow
The study was conducted in the US between 13Dec2017 and 09Nov2018.
A total of 248 participants consented to participate in the study, of which 115 were screen failures. A total of 133 participants were randomized to the study of which only 132 received treatment. One participant was ineligible, being randomized by error but not followed or treated.
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
24
|
22
|
21
|
22
|
|
Overall Study
COMPLETED
|
23
|
19
|
24
|
21
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
67.4 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
64.7 Years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
67.5 Years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
67.6 Years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
66.3 Years
STANDARD_DEVIATION 8.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
115 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
125 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 241Population: As-treated population: All participants who received any dose of study drug and analyzed according to actual treatment they received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated anti-drug antibodies (ADA), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) levels at Day 151 visit.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
17 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 241Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 241Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 241Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 241Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), and Days 31, 61, and 91Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.
Change from baseline in apolipoprotein B is reported.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein B
Day 31
|
3.3 mg/dL
Standard Deviation 8.5
|
0.5 mg/dL
Standard Deviation 12.2
|
5.1 mg/dL
Standard Deviation 10.6
|
2.2 mg/dL
Standard Deviation 9.4
|
7.1 mg/dL
Standard Deviation 10.6
|
7.1 mg/dL
Standard Deviation 14.3
|
|
Change From Baseline in Apolipoprotein B
Day 61
|
1.2 mg/dL
Standard Deviation 13.9
|
-1.2 mg/dL
Standard Deviation 14.1
|
3.5 mg/dL
Standard Deviation 10.8
|
2.6 mg/dL
Standard Deviation 15.3
|
3.7 mg/dL
Standard Deviation 11.7
|
6.2 mg/dL
Standard Deviation 9.6
|
|
Change From Baseline in Apolipoprotein B
Day 91
|
-0.5 mg/dL
Standard Deviation 10.7
|
3.6 mg/dL
Standard Deviation 29.3
|
2.3 mg/dL
Standard Deviation 10.7
|
2.0 mg/dL
Standard Deviation 8.3
|
2.9 mg/dL
Standard Deviation 9.4
|
7.8 mg/dL
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), and Days 31, 61, and 91Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.
Percent change from baseline in HDL-C is reported.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Day 31
|
-3.08 Percent change
Standard Deviation 10.28
|
7.37 Percent change
Standard Deviation 13.52
|
22.95 Percent change
Standard Deviation 25.04
|
27.25 Percent change
Standard Deviation 19.37
|
44.12 Percent change
Standard Deviation 24.74
|
55.80 Percent change
Standard Deviation 25.97
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Day 61
|
-4.69 Percent change
Standard Deviation 9.45
|
4.58 Percent change
Standard Deviation 12.45
|
28.28 Percent change
Standard Deviation 32.19
|
37.65 Percent change
Standard Deviation 22.76
|
39.74 Percent change
Standard Deviation 22.74
|
49.58 Percent change
Standard Deviation 21.46
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Day 91
|
-3.62 Percent change
Standard Deviation 13.41
|
1.98 Percent change
Standard Deviation 14.69
|
21.82 Percent change
Standard Deviation 30.66
|
35.63 Percent change
Standard Deviation 35.27
|
43.29 Percent change
Standard Deviation 31.09
|
48.31 Percent change
Standard Deviation 25.63
|
SECONDARY outcome
Timeframe: Day 61 (pre-dose), and on Days 64, 68, 71, and 91Population: Pharmacokinetic (PK) evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
AUC30d after the last dose of MEDI5884 is reported.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=22 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=20 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=20 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=20 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
|
14.6 μg⋅day/mL
Standard Deviation 27.3
|
51.8 μg⋅day/mL
Standard Deviation 54.8
|
191 μg⋅day/mL
Standard Deviation 176
|
584 μg⋅day/mL
Standard Deviation 294
|
1020 μg⋅day/mL
Standard Deviation 643
|
—
|
SECONDARY outcome
Timeframe: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151Population: The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=22 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=20 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=20 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=20 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
|
1.01 μg/mL
Standard Deviation 1.34
|
4.63 μg/mL
Standard Deviation 2.95
|
11.9 μg/mL
Standard Deviation 7.77
|
28.5 μg/mL
Standard Deviation 13.0
|
46.3 μg/mL
Standard Deviation 24.6
|
—
|
SECONDARY outcome
Timeframe: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151Population: The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Outcome measures
| Measure |
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=2 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=7 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=14 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=14 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
|
—
|
7.56 Days
Standard Deviation 6.4
|
8.09 Days
Standard Deviation 2.80
|
10.3 Days
Standard Deviation 3.53
|
13.7 Days
Standard Deviation 5.86
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241Population: As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 Participants
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 Participants
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 Participants
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 Participants
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 Participants
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI5884 50 mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI5884 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI5884 200 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MEDI5884 350 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
MEDI5884 500 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 participants at risk
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 participants at risk
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 participants at risk
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 participants at risk
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 participants at risk
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
9.5%
2/21 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Vascular disorders
Peripheral artery occlusion
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
|
MEDI5884 50 mg
n=20 participants at risk
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
|
MEDI5884 100 mg
n=24 participants at risk
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
|
MEDI5884 200 mg
n=22 participants at risk
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
|
MEDI5884 350 mg
n=21 participants at risk
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
|
MEDI5884 500 mg
n=22 participants at risk
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Hordeolum
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
General disorders
Influenza like illness
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
General disorders
Injection site bruising
|
8.7%
2/23 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
General disorders
Injection site erythema
|
8.7%
2/23 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
13.6%
3/22 • Number of events 5 • Day 1 through Day 241
|
19.0%
4/21 • Number of events 12 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
General disorders
Injection site swelling
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
General disorders
Oedema peripheral
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Furuncle
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
9.5%
2/21 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
9.1%
2/22 • Number of events 2 • Day 1 through Day 241
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
9.5%
2/21 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
9.5%
2/21 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
9.5%
2/21 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Investigations
Apolipoprotein b increased
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Investigations
Crystal urine present
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Investigations
Liver function test increased
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
10.0%
2/20 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
2/23 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
10.0%
2/20 • Number of events 2 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
4.5%
1/22 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
0.00%
0/21 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1 • Day 1 through Day 241
|
5.0%
1/20 • Number of events 1 • Day 1 through Day 241
|
4.2%
1/24 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/23 • Day 1 through Day 241
|
0.00%
0/20 • Day 1 through Day 241
|
0.00%
0/24 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
4.8%
1/21 • Number of events 1 • Day 1 through Day 241
|
0.00%
0/22 • Day 1 through Day 241
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER