Trial Outcomes & Findings for A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults (NCT NCT02114268)
NCT ID: NCT02114268
Last Updated: 2016-11-28
Results Overview
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
342 participants
Primary outcome timeframe
From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
Results posted on
2016-11-28
Participant Flow
There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.
Participant milestones
| Measure |
Placebo
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
6
|
6
|
6
|
6
|
78
|
|
Overall Study
COMPLETED
|
28
|
5
|
5
|
6
|
6
|
75
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
1
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawn by site due to noncompliance
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=6 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
n=78 Participants
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.2 Years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
34.5 Years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
34.3 Years
STANDARD_DEVIATION 5.6 • n=27 Participants
|
33.5 Years
STANDARD_DEVIATION 6.7 • n=483 Participants
|
30.7 Years
STANDARD_DEVIATION 7.8 • n=36 Participants
|
30.3 Years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
30.5 Years
STANDARD_DEVIATION 8.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)Population: The As-treated population included participants who receive any study investigational product.
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=6 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
n=78 Participants
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
21 participants
|
3 participants
|
3 participants
|
5 participants
|
4 participants
|
48 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
|
2 participants
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=78 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
|
0.078 Day
Standard Deviation 172
|
0.059 Day
Standard Deviation 0
|
0.209 Day
Standard Deviation 62.7
|
5.46 Day
Standard Deviation 71.4
|
9.42 Day
Standard Deviation 78.4
|
—
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=78 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for MEDI8897
|
96.98 microgram per milliliter (mcg/ml)
Standard Deviation 21.9
|
333.80 microgram per milliliter (mcg/ml)
Standard Deviation 22.4
|
1163.32 microgram per milliliter (mcg/ml)
Standard Deviation 23.8
|
20.40 microgram per milliliter (mcg/ml)
Standard Deviation 29.4
|
47.48 microgram per milliliter (mcg/ml)
Standard Deviation 26.2
|
—
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=75 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
|
6714.75 Day*microgram per milliliter
Standard Deviation 21.7
|
25320.68 Day*microgram per milliliter
Standard Deviation 17
|
63580.33 Day*microgram per milliliter
Standard Deviation 10.4
|
2249.11 Day*microgram per milliliter
Standard Deviation 17.9
|
5193.73 Day*microgram per milliliter
Standard Deviation 32.1
|
—
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=75 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2) for MEDI8897
|
116.52 Day
Standard Deviation 19.6
|
92.0 Day
Standard Deviation 12.6
|
89.81 Day
Standard Deviation 18.2
|
102.61 Day
Standard Deviation 11.3
|
85.29 Day
Standard Deviation 30.8
|
—
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=75 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) for MEDI8897
|
46.05 ml per day
Standard Deviation 17.3
|
40.33 ml per day
Standard Deviation 15.4
|
47.60 ml per day
Standard Deviation 10.6
|
45.46 ml per day
Standard Deviation 15.4
|
64.60 ml per day
Standard Deviation 37.7
|
—
|
SECONDARY outcome
Timeframe: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=5 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=75 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz) for MEDI8897
|
7694.15 milliliter (ml)
Standard Deviation 24.8
|
5426.89 milliliter (ml)
Standard Deviation 26.7
|
6137.69 milliliter (ml)
Standard Deviation 18.5
|
6808.78 milliliter (ml)
Standard Deviation 24.5
|
7455.90 milliliter (ml)
Standard Deviation 34.0
|
—
|
SECONDARY outcome
Timeframe: Predose and Day 15, 31, 91, 181, 271 and 361Population: The As-treated Population included participants who receive any study investigational product.
Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 Participants
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=6 Participants
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
n=78 Participants
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA)
Predose
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA)
At Any Time Postdose
|
5 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
13 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
MEDI8897 300 Milligram (mg) Intravenous (IV)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI8897 1000 Milligram (mg) Intravenous (IV)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI8897 3000 Milligram (mg) Intravenous (IV)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI8897 100 Milligram (mg) Intramuscular (IM)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI8897 300 Milligram (mg) Intramuscular (IM)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=34 participants at risk
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=6 participants at risk
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
n=78 participants at risk
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Participants received placebo on Day 1.
|
MEDI8897 300 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 1000 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 3000 Milligram (mg) Intravenous (IV)
n=6 participants at risk
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
MEDI8897 100 Milligram (mg) Intramuscular (IM)
n=6 participants at risk
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
MEDI8897 300 Milligram (mg) Intramuscular (IM)
n=78 participants at risk
Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Psychiatric disorders
Depression
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Eye disorders
Blepharospasm
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Eye disorders
Lacrimation increased
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Eye disorders
Vision blurred
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
3.8%
3/78 • Number of events 3 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
33.3%
2/6 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
3.8%
3/78 • Number of events 3 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Salivary gland pain
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
6.4%
5/78 • Number of events 5 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Cyst
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Drug intolerance
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Fatigue
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Infusion site erythema
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Injection site pain
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
General disorders
Pyrexia
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Immune system disorders
Seasonal allergy
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
2.6%
2/78 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Candida infection
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Cellulitis
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Injection site infection
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
2.6%
2/78 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Staphylococcal infection
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
3/34 • Number of events 3 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
20.5%
16/78 • Number of events 19 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
33.3%
2/6 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
5.1%
4/78 • Number of events 5 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Laceration
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
2/34 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
3.8%
3/78 • Number of events 3 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
5.1%
4/78 • Number of events 4 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Headache
|
17.6%
6/34 • Number of events 6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
9.0%
7/78 • Number of events 8 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Nervous system disorders
Paraesthesia
|
5.9%
2/34 • Number of events 2 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
5.1%
4/78 • Number of events 4 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.9%
1/34 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/78 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
16.7%
1/6 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
3.8%
3/78 • Number of events 3 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/34 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
0.00%
0/6 • From Screening to Postdose Follow-up (up to 391 Days)
|
1.3%
1/78 • Number of events 1 • From Screening to Postdose Follow-up (up to 391 Days)
|
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.
- Publication restrictions are in place
Restriction type: OTHER