Trial Outcomes & Findings for A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL (NCT NCT01544348)
NCT ID: NCT01544348
Last Updated: 2014-12-30
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
295 participants
Primary outcome timeframe
Day 1 to 85
Results posted on
2014-12-30
Participant Flow
A total of 295 participants were screened, out of which 209 were screen failures and 86 were randomized.
Participant milestones
| Measure |
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
6
|
3
|
3
|
16
|
19
|
14
|
8
|
|
Overall Study
Treated
|
17
|
6
|
3
|
3
|
15
|
18
|
14
|
8
|
|
Overall Study
COMPLETED
|
15
|
6
|
3
|
3
|
15
|
16
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
1
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=6 Participants
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=15 Participants
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=18 Participants
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=14 Participants
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
n=8 Participants
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
40.3 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
35.9 years
STANDARD_DEVIATION 13.1 • n=8 Participants
|
38.0 years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
39.0 years
STANDARD_DEVIATION 11.2 • n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
62 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 85Population: Safety population included all participants who received any amount of investigational product and had safety data available.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=6 Participants
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=15 Participants
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=18 Participants
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=14 Participants
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
n=8 Participants
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
8 participants
|
2 participants
|
2 participants
|
1 participants
|
4 participants
|
9 participants
|
7 participants
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85Population: Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Outcome measures
| Measure |
Placebo
n=6 Participants
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=3 Participants
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=15 Participants
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=18 Participants
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=14 Participants
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=8 Participants
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Observed Serum Concentration
Day 1 (predose) (n=0,1,0,0,2,1,1)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
96.76 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
254.71 nanogram per milliliter (ng/mL)
Standard Deviation 134.58
|
91.69 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
158.32 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
|
Observed Serum Concentration
Day 1 (postdose) (n=0,0,0,0,0,0,8)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
110693 nanogram per milliliter (ng/mL)
Standard Deviation 26060.2
|
—
|
|
Observed Serum Concentration
Day 2 (n=5,1,1,12,17,13,8)
|
8941.12 nanogram per milliliter (ng/mL)
Standard Deviation 6361.95
|
100.36 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
292.76 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3146.54 nanogram per milliliter (ng/mL)
Standard Deviation 3820.61
|
6108.21 nanogram per milliliter (ng/mL)
Standard Deviation 3401.45
|
14971.9 nanogram per milliliter (ng/mL)
Standard Deviation 9608.63
|
88457.0 nanogram per milliliter (ng/mL)
Standard Deviation 23398.4
|
—
|
|
Observed Serum Concentration
Day 3 (n=5,1,1,12,17,14,8)
|
13912.4 nanogram per milliliter (ng/mL)
Standard Deviation 7546.50
|
110.12 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
312.73 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3131.79 nanogram per milliliter (ng/mL)
Standard Deviation 2513.43
|
7969.07 nanogram per milliliter (ng/mL)
Standard Deviation 4004.75
|
14771 nanogram per milliliter (ng/mL)
Standard Deviation 8692.16
|
69776.5 nanogram per milliliter (ng/mL)
Standard Deviation 37738.7
|
—
|
|
Observed Serum Concentration
Day 5 (n=5,1,1,11,16,14,8)
|
17016.3 nanogram per milliliter (ng/mL)
Standard Deviation 6806.15
|
116.44 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
284.28 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
3336.31 nanogram per milliliter (ng/mL)
Standard Deviation 2759.69
|
7227.93 nanogram per milliliter (ng/mL)
Standard Deviation 3210.9
|
15183.4 nanogram per milliliter (ng/mL)
Standard Deviation 8522.98
|
34359.5 nanogram per milliliter (ng/mL)
Standard Deviation 6817.40
|
—
|
|
Observed Serum Concentration
Day 8 (n=5,0,1,9,16,14,8)
|
16467.4 nanogram per milliliter (ng/mL)
Standard Deviation 5374.97
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
190.38 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
2368.21 nanogram per milliliter (ng/mL)
Standard Deviation 1364.28
|
7144.03 nanogram per milliliter (ng/mL)
Standard Deviation 5078.61
|
12611.1 nanogram per milliliter (ng/mL)
Standard Deviation 8382.56
|
39290.2 nanogram per milliliter (ng/mL)
Standard Deviation 32657.3
|
—
|
|
Observed Serum Concentration
Day 15 (n=5,0,0,7,14,13,8)
|
15099.6 nanogram per milliliter (ng/mL)
Standard Deviation 5470.44
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
1134.39 nanogram per milliliter (ng/mL)
Standard Deviation 259.41
|
4514.83 nanogram per milliliter (ng/mL)
Standard Deviation 2864.46
|
8824.94 nanogram per milliliter (ng/mL)
Standard Deviation 6744.55
|
11391.2 nanogram per milliliter (ng/mL)
Standard Deviation 3673.21
|
—
|
|
Observed Serum Concentration
Day 22 (n=5,0,0,6,12,10,8)
|
12780.2 nanogram per milliliter (ng/mL)
Standard Deviation 4657.23
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
521.3 nanogram per milliliter (ng/mL)
Standard Deviation 96.73
|
3401 nanogram per milliliter (ng/mL)
Standard Deviation 2140.78
|
7454.01 nanogram per milliliter (ng/mL)
Standard Deviation 4682.86
|
4644.04 nanogram per milliliter (ng/mL)
Standard Deviation 2571.96
|
—
|
|
Observed Serum Concentration
Day 29 (n=5,0,0,4,11,8,7)
|
9466.26 nanogram per milliliter (ng/mL)
Standard Deviation 4040.07
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
212.22 nanogram per milliliter (ng/mL)
Standard Deviation 82.96
|
2176.59 nanogram per milliliter (ng/mL)
Standard Deviation 1390.94
|
2688.85 nanogram per milliliter (ng/mL)
Standard Deviation 2191.8
|
2045.55 nanogram per milliliter (ng/mL)
Standard Deviation 1814.12
|
—
|
|
Observed Serum Concentration
Day 43 (n=5,2,0,0,5,5,3)
|
5195.21 nanogram per milliliter (ng/mL)
Standard Deviation 2263.08
|
121.39 nanogram per milliliter (ng/mL)
Standard Deviation 8.11
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
1544.4 nanogram per milliliter (ng/mL)
Standard Deviation 2068.43
|
1188.63 nanogram per milliliter (ng/mL)
Standard Deviation 949.33
|
1669.74 nanogram per milliliter (ng/mL)
Standard Deviation 739.22
|
—
|
|
Observed Serum Concentration
Day 57 (n=5,2,0,0,4,4,3)
|
2367.85 nanogram per milliliter (ng/mL)
Standard Deviation 984.70
|
122.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.35
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
290.44 nanogram per milliliter (ng/mL)
Standard Deviation 228.81
|
485.18 nanogram per milliliter (ng/mL)
Standard Deviation 249.73
|
150.90 nanogram per milliliter (ng/mL)
Standard Deviation 87.96
|
—
|
|
Observed Serum Concentration
Day 85 (n=5,2,0,1, 3,1,1)
|
829.55 nanogram per milliliter (ng/mL)
Standard Deviation 434.33
|
104.07 nanogram per milliliter (ng/mL)
Standard Deviation 2.48
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
98.62 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
202.54 nanogram per milliliter (ng/mL)
Standard Deviation 107.75
|
84.03 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
176.87 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
|
—
|
SECONDARY outcome
Timeframe: Days 1 (pre-dose), 15, 43, and 85Population: Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=3 Participants
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=15 Participants
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=18 Participants
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=14 Participants
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=8 Participants
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group onlyPopulation: Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=6 Participants
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=3 Participants
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=15 Participants
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=18 Participants
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=14 Participants
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
n=8 Participants
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day -28 (n=16,6,3,3,14,15,13,8)
|
1160.79 ng/mL
Standard Deviation 1402.74
|
478.99 ng/mL
Standard Deviation 369.31
|
655.76 ng/mL
Standard Deviation 240.78
|
601.40 ng/mL
Standard Deviation 342.13
|
2170.63 ng/mL
Standard Deviation 3899.67
|
1976.98 ng/mL
Standard Deviation 3172.11
|
1775.68 ng/mL
Standard Deviation 2558.08
|
2641.68 ng/mL
Standard Deviation 2332.13
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day -1 (n=17,6,3,3,15,17,14,7)
|
1025.19 ng/mL
Standard Deviation 1287.86
|
296.73 ng/mL
Standard Deviation 185.09
|
589.62 ng/mL
Standard Deviation 175.14
|
522.23 ng/mL
Standard Deviation 259.96
|
2453.85 ng/mL
Standard Deviation 3795.64
|
1655.06 ng/mL
Standard Deviation 2866.87
|
1681.82 ng/mL
Standard Deviation 2161.25
|
2772.55 ng/mL
Standard Deviation 2320.93
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 1 (Predose) (n=17,6,3,3,15,17,14,8)
|
1155.59 ng/mL
Standard Deviation 1447.09
|
410.78 ng/mL
Standard Deviation 289.39
|
552.30 ng/mL
Standard Deviation 168.96
|
558.69 ng/mL
Standard Deviation 305.68
|
2754.09 ng/mL
Standard Deviation 4468.96
|
1910.45 ng/mL
Standard Deviation 3268.58
|
1850.27 ng/mL
Standard Deviation 2435.13
|
2426.66 ng/mL
Standard Deviation 2460.85
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8)
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
NA ng/mL
Standard Deviation NA
No participant was evaluable for this outcome measure at this time point.
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 2 (n=17,6,3,3,15,17,14,8)
|
1183.10 ng/mL
Standard Deviation 1494.92
|
71.89 ng/mL
Standard Deviation 157.68
|
302.31 ng/mL
Standard Deviation 195.18
|
336.75 ng/mL
Standard Deviation 294.36
|
1584.76 ng/mL
Standard Deviation 3999.13
|
366.83 ng/mL
Standard Deviation 1499.49
|
94.19 ng/mL
Standard Deviation 351.27
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 3 (n=17,6,3,3,15,17,14,8)
|
1175.50 ng/mL
Standard Deviation 1550.93
|
74.29 ng/mL
Standard Deviation 168.46
|
282.12 ng/mL
Standard Deviation 179.53
|
293.78 ng/mL
Standard Deviation 259.88
|
1366.58 ng/mL
Standard Deviation 3496.19
|
248.20 ng/mL
Standard Deviation 1022.97
|
42.24 ng/mL
Standard Deviation 157.38
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 5 (n=17,6,3,3,15,17,14,8)
|
1131.87 ng/mL
Standard Deviation 1448.24
|
74.85 ng/mL
Standard Deviation 169.36
|
297.90 ng/mL
Standard Deviation 193.62
|
277.94 ng/mL
Standard Deviation 240.84
|
1401.33 ng/mL
Standard Deviation 3429.60
|
253.71 ng/mL
Standard Deviation 1045.75
|
0.53 ng/mL
Standard Deviation 1.43
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 8 (n=17,6,3,3,15,17,14,8)
|
1119.38 ng/mL
Standard Deviation 1417.95
|
85.00 ng/mL
Standard Deviation 192.16
|
366.17 ng/mL
Standard Deviation 239.65
|
288.20 ng/mL
Standard Deviation 250.03
|
1704.44 ng/mL
Standard Deviation 3822.59
|
362.27 ng/mL
Standard Deviation 1408.50
|
3.17 ng/mL
Standard Deviation 10.71
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 15 (n=17,6,3,3,15,17,14,8)
|
1081.11 ng/mL
Standard Deviation 1338.94
|
74.94 ng/mL
Standard Deviation 161.38
|
418.27 ng/mL
Standard Deviation 193.63
|
362.06 ng/mL
Standard Deviation 246.96
|
2102.53 ng/mL
Standard Deviation 4140.14
|
978.17 ng/mL
Standard Deviation 2490.21
|
209.71 ng/mL
Standard Deviation 539.11
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 22 (n=17,6,3,3,15,17,14,8)
|
1084.02 ng/mL
Standard Deviation 1294.17
|
70.95 ng/mL
Standard Deviation 145.36
|
453.89 ng/mL
Standard Deviation 191.07
|
406.12 ng/mL
Standard Deviation 264.19
|
2111.36 ng/mL
Standard Deviation 3730.60
|
1351.52 ng/mL
Standard Deviation 2803.98
|
788.30 ng/mL
Standard Deviation 1783.50
|
0.32 ng/mL
Standard Deviation 0.60
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 29 (n=16,6,3,3,15,17,13,8)
|
1185.82 ng/mL
Standard Deviation 1379.20
|
74.02 ng/mL
Standard Deviation 143.04
|
478.53 ng/mL
Standard Deviation 196.36
|
403.17 ng/mL
Standard Deviation 232.44
|
2153.91 ng/mL
Standard Deviation 3376.54
|
1676.12 ng/mL
Standard Deviation 3296.43
|
1468.72 ng/mL
Standard Deviation 3043.16
|
497.42 ng/mL
Standard Deviation 628.41
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 43 (n=16,6,3,3,15,16,13,8)
|
1089.90 ng/mL
Standard Deviation 1306.97
|
89.32 ng/mL
Standard Deviation 157.95
|
496.28 ng/mL
Standard Deviation 179.01
|
510.78 ng/mL
Standard Deviation 301.83
|
2712.59 ng/mL
Standard Deviation 4065.37
|
1928.37 ng/mL
Standard Deviation 3371.88
|
1912.71 ng/mL
Standard Deviation 2966.45
|
1674.54 ng/mL
Standard Deviation 1689.61
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 57 (n=16,6,3,3,15,15,12,8)
|
1055.20 ng/mL
Standard Deviation 1257.08
|
105.46 ng/mL
Standard Deviation 159.88
|
506.63 ng/mL
Standard Deviation 205.91
|
503.33 ng/mL
Standard Deviation 326.80
|
2201.38 ng/mL
Standard Deviation 3609.05
|
1394.92 ng/mL
Standard Deviation 2394.88
|
2306.44 ng/mL
Standard Deviation 3511.87
|
1978.31 ng/mL
Standard Deviation 1906.57
|
|
Free Immunoglobulin E (IgE) Serum Concentration
Day 85 (n=15,6,3,3,15,16,12,8)
|
913.17 ng/mL
Standard Deviation 1142.25
|
294.89 ng/mL
Standard Deviation 377.39
|
526.93 ng/mL
Standard Deviation 227.80
|
530.49 ng/mL
Standard Deviation 292.24
|
2014.95 ng/mL
Standard Deviation 2952.69
|
1749.34 ng/mL
Standard Deviation 2799.68
|
2528.85 ng/mL
Standard Deviation 3967.57
|
2055.68 ng/mL
Standard Deviation 1822.85
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Omalizumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI4212 5 mg Subcutaneous
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI4212 15 mg Subcutaneous
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MEDI4212 60 mg Subcutaneous
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI4212 150 mg Subcutaneous
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI4212 300 mg Subcutaneous
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI4212 300 mg Intravenous
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
|
Omalizumab
n=6 participants at risk
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
|
MEDI4212 5 mg Subcutaneous
n=3 participants at risk
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
|
MEDI4212 15 mg Subcutaneous
n=3 participants at risk
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
|
MEDI4212 60 mg Subcutaneous
n=15 participants at risk
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
|
MEDI4212 150 mg Subcutaneous
n=18 participants at risk
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Subcutaneous
n=14 participants at risk
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
|
MEDI4212 300 mg Intravenous
n=8 participants at risk
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Ear and labyrinth disorders
Ear congestion
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Eye disorders
Eye irritation
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Eye disorders
Vision blurred
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Feeling hot
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Injection site bruising
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Injection site pain
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
25.0%
2/8 • Number of events 2 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Infections and infestations
Upper respiratory tract infection
|
35.3%
6/17 • Number of events 6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
11.1%
2/18 • Number of events 2 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
14.3%
2/14 • Number of events 3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
25.0%
2/8 • Number of events 2 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
16.7%
1/6 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
5.6%
1/18 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
14.3%
2/14 • Number of events 2 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
6.7%
1/15 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
7.1%
1/14 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
16.7%
1/6 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
33.3%
1/3 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/8 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
16.7%
3/18 • Number of events 3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
25.0%
2/8 • Number of events 2 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/6 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/3 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/15 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/18 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
0.00%
0/14 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
12.5%
1/8 • Number of events 1 • Day 1 to 85
Safety population included all participants who received any amount of investigational product and had safety data available.
|
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 ongoing 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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER