Trial Outcomes & Findings for Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001) (NCT NCT01025843)
NCT ID: NCT01025843
Last Updated: 2018-09-21
Results Overview
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Up to 14 days after administration of last dose of study drug (up to Day 52)
Results posted on
2018-09-21
Participant Flow
A Part II of this study was planned. However, since the efficacy criteria for advancing to Part II were not met in Part I, this study was considered completed with the completion of Part I. Therefore participants were not recruited for Part II.
Participant milestones
| Measure |
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan → Pbo → 12 mg → 24 mg → 38 mg
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
|
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → 5 mg → 12 mg → Candesartan → Pbo
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → Candesartan → Pbo → 24 mg → 38 mg
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
|
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
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Period 1
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Reasons for withdrawal
| Measure |
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan → Pbo → 12 mg → 24 mg → 38 mg
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
|
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → 5 mg → 12 mg → Candesartan → Pbo
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → Candesartan → Pbo → 24 mg → 38 mg
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → 5 mg → 12 mg → Pbo → Candesartan
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
|
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
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Washout 4
Withdrawal by Subject
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1
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0
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Baseline Characteristics
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Baseline characteristics by cohort
| Measure |
Pbo → 5 mg → Candesartan → 24 mg → 38 mg
n=2 Participants
Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
|
1 mg → 5 mg → 12 mg → Candesartan → Pbo
n=2 Participants
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → Candesartan → Pbo → 24 mg → 38 mg
n=2 Participants
1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
1 mg → 5 mg → 12 mg → Pbo → Candesartan
n=2 Participants
1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
|
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan
n=2 Participants
Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
|
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg
n=2 Participants
2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg
n=2 Participants
2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo
n=2 Participants
2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg
n=2 Participants
Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
|
Candesartan → Pbo → 12 mg → 24 mg → 38 mg
n=2 Participants
Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
|
Total
n=20 Participants
Total of all reporting groups
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|---|---|---|---|---|---|---|---|---|---|---|---|
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Age, Continuous
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46.5 Years
n=5 Participants
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38.5 Years
n=7 Participants
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46.0 Years
n=5 Participants
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35.0 Years
n=4 Participants
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37.5 Years
n=21 Participants
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44.5 Years
n=8 Participants
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48.0 Years
n=8 Participants
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46.5 Years
n=24 Participants
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45.0 Years
n=42 Participants
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39.0 Years
n=42 Participants
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45.5 Years
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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0 Participants
n=4 Participants
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0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
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0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
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2 Participants
n=7 Participants
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2 Participants
n=5 Participants
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2 Participants
n=4 Participants
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2 Participants
n=21 Participants
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2 Participants
n=8 Participants
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2 Participants
n=8 Participants
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2 Participants
n=24 Participants
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2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
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20 Participants
n=42 Participants
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PRIMARY outcome
Timeframe: Up to 14 days after administration of last dose of study drug (up to Day 52)Population: All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Outcome measures
| Measure |
MK-5478 1 mg
n=6 Participants
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 5 mg
n=6 Participants
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 8 mg
n=6 Participants
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 12 mg
n=6 Participants
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 18 mg
n=6 Participants
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 24 mg
n=6 Participants
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 38 mg
n=5 Participants
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg - Fed
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan 32 mg
n=15 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
|
Candesartan 32 mg - Fed
n=2 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan Placebo
n=2 Participants
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
|
MK-5478 Placebo
n=16 Participants
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants With One or More Adverse Events (AEs)
|
5 Participants
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3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
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3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours after administration of study drugPopulation: All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Outcome measures
| Measure |
MK-5478 1 mg
n=6 Participants
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 5 mg
n=6 Participants
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 8 mg
n=6 Participants
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 12 mg
n=6 Participants
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 18 mg
n=6 Participants
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 24 mg
n=6 Participants
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 38 mg
n=5 Participants
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg - Fed
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan 32 mg
n=15 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
|
Candesartan 32 mg - Fed
n=2 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan Placebo
n=2 Participants
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
|
MK-5478 Placebo
n=16 Participants
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants Who Discontinued Treatment Due to an AE
|
0 Participants
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0 Participants
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0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and up to 48 hours postdosePopulation: In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan
Outcome measures
| Measure |
MK-5478 1 mg
n=6 Participants
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 5 mg
n=6 Participants
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 8 mg
n=6 Participants
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 12 mg
n=6 Participants
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 18 mg
n=6 Participants
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 24 mg
n=6 Participants
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 38 mg
n=6 Participants
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg - Fed
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan 32 mg
n=16 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
|
Candesartan 32 mg - Fed
n=2 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan Placebo
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
|
MK-5478 Placebo
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
|
0.236 umol.hr/L
Standard Deviation 0.141
|
0.494 umol.hr/L
Standard Deviation 0.202
|
1.87 umol.hr/L
Standard Deviation 0.538
|
1.80 umol.hr/L
Standard Deviation 0.436
|
1.36 umol.hr/L
Standard Deviation 0.448
|
2.23 umol.hr/L
Standard Deviation 0.582
|
3.15 umol.hr/L
Standard Deviation 1.55
|
4.50 umol.hr/L
Standard Deviation 0.857
|
0.504 umol.hr/L
Standard Deviation 0.07
|
5.89 umol.hr/L
Standard Deviation 1.38
|
4.46 umol.hr/L
Standard Deviation 0.314
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 to 3 hours postdosePopulation: Results were not analyzed because none showed a \> 5% decrease in AIx.
Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a \> 5% decrease in AIx were planned for analysis; results with a \< 5% decrease in AIx were not analysed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and up to 48 hours postdosePopulation: In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan
Outcome measures
| Measure |
MK-5478 1 mg
n=6 Participants
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 5 mg
n=6 Participants
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 8 mg
n=6 Participants
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 12 mg
n=6 Participants
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 18 mg
n=6 Participants
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 24 mg
n=6 Participants
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 38 mg
n=6 Participants
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg - Fed
n=6 Participants
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan 32 mg
n=16 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
|
Candesartan 32 mg - Fed
n=2 Participants
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan Placebo
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
|
MK-5478 Placebo
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
|
0.0291 µmol/L
Standard Deviation 0.012
|
0.0573 µmol/L
Standard Deviation 0.0206
|
0.254 µmol/L
Standard Deviation 0.0588
|
0.227 µmol/L
Standard Deviation 0.0630
|
0.120 µmol/L
Standard Deviation 0.0332
|
0.245 µmol/L
Standard Deviation 0.0634
|
0.321 µmol/L
Standard Deviation 0.206
|
0.532 µmol/L
Standard Deviation 0.154
|
0.0553 µmol/L
Standard Deviation 0.00891
|
0.476 µmol/L
Standard Deviation 0.194
|
0.451 µmol/L
Standard Deviation 0.0641
|
—
|
—
|
Adverse Events
MK-5478 1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-5478 2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-5478 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-5478 8 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-5478 12 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-5478 18 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-5478 24 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-5478 38 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-5478 2 mg - Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-5478 Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Candesartan 32 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Candesartan 32 mg - Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Candesartan Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-5478 1 mg
n=6 participants at risk
A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg
n=6 participants at risk
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 5 mg
n=6 participants at risk
A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 8 mg
n=6 participants at risk
.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 12 mg
n=6 participants at risk
A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 18 mg
n=6 participants at risk
A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 24 mg
n=6 participants at risk
A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 38 mg
n=5 participants at risk
A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
|
MK-5478 2 mg - Fed
n=6 participants at risk
A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
|
MK-5478 Placebo
n=16 participants at risk
A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
|
Candesartan 32 mg
n=15 participants at risk
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
|
Candesartan 32 mg - Fed
n=2 participants at risk
A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
|
Candesartan Placebo
n=2 participants at risk
A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
33.3%
2/6 • Number of events 3 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Loose stools
|
33.3%
2/6 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
20.0%
1/5 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
General disorders
Fatigue
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
General disorders
Infusion site haematoma
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
General disorders
Thirst
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
33.3%
2/6 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
20.0%
1/5 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
20.0%
1/5 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
33.3%
2/6 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
18.8%
3/16 • Number of events 3 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
13.3%
2/15 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
50.0%
1/2 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Vascular disorders
Facial flushing
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.2%
1/16 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
16.7%
1/6 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/15 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/5 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/6 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/16 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
6.7%
1/15 • Number of events 1 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
0.00%
0/2 • 14 days after administration of last dose of study drug (up to Day 52)
All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER