Trial Outcomes & Findings for Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002) (NCT NCT01532973)
NCT ID: NCT01532973
Last Updated: 2018-07-17
Results Overview
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
Results posted on
2018-07-17
Participant Flow
2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.
Participant milestones
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 200-mg Elbasvir (Panel D)
Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT3 HCV 10-mg Elbasvir (Panel E)
Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
|
GT3 HCV 50-mg Elbasvir (Panel F)
Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
|
GT3 HCV 100-mg Elbasvir (Panel G)
Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
|
GT3 HCV 200-mg Elbasvir (Panel H)
Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
|
GT1a HCV 10-mg Elbasvir (Panel I)
Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
|
GT1a HCV 50-mg Elbasvir (Panel J)
Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Part 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Part 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)
Baseline characteristics by cohort
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=5 Participants
Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
|
GT3 HCV 10-mg Elbasvir (Panel E)
n=5 Participants
Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
|
GT3 HCV 50-mg Elbasvir (Panel F)
n=5 Participants
Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
|
GT3 HCV 100-mg Elbasvir (Panel G)
n=5 Participants
Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
|
GT1a HCV 10-mg Elbasvir (Panel I)
n=5 Participants
Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
|
GT1a HCV 50-mg Elbasvir (Panel J)
n=5 Participants
Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
|
Placebo
n=8 Participants
Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
36.8 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
51.6 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
34.8 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 8.9 • n=31 Participants
|
34.6 years
STANDARD_DEVIATION 6.8 • n=30 Participants
|
51.0 years
STANDARD_DEVIATION 5.0 • n=3 Participants
|
53.2 years
STANDARD_DEVIATION 11.6 • n=6 Participants
|
47.8 years
STANDARD_DEVIATION 10.8 • n=114 Participants
|
43.0 years
STANDARD_DEVIATION 11.0
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5Population: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=5 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1
|
4.25 IU/mL
Interval 3.8 to 4.71
|
4.40 IU/mL
Interval 3.95 to 4.86
|
3.56 IU/mL
Interval 3.1 to 4.02
|
0.00 IU/mL
Interval -0.37 to 0.36
|
—
|
PRIMARY outcome
Timeframe: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5Population: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=5 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3
|
1.01 IU/mL
Interval 0.38 to 1.65
|
2.06 IU/mL
Interval 1.43 to 2.7
|
2.72 IU/mL
Interval 2.08 to 3.35
|
0.00 IU/mL
Interval -0.5 to 0.5
|
—
|
PRIMARY outcome
Timeframe: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5Population: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=8 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a
|
3.20 IU/mL
Interval 2.71 to 3.68
|
3.95 IU/mL
Interval 3.46 to 4.43
|
0.00 IU/mL
Interval -0.39 to 0.38
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=5 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1
|
4.44 IU/mL
Interval 3.78 to 5.09
|
5.21 IU/mL
Interval 4.56 to 5.87
|
4.15 IU/mL
Interval 3.5 to 4.81
|
0.54 IU/mL
Interval 0.03 to 1.06
|
—
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=5 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3
|
1.27 IU/mL
Interval 0.49 to 2.04
|
3.12 IU/mL
Interval 2.34 to 3.89
|
3.38 IU/mL
Interval 2.61 to 4.16
|
0.54 IU/mL
Interval -0.07 to 1.16
|
—
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=5 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=8 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a
|
3.72 IU/mL
Interval 3.12 to 4.31
|
4.17 IU/mL
Interval 3.57 to 4.77
|
0.54 IU/mL
Interval 0.07 to 1.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the 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 was temporally associated with the use of the product, was also an AE.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=15 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=15 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=5 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5
|
4 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the 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 was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.
Outcome measures
| Measure |
GT1 HCV 10-mg Elbasvir (Panel A)
n=5 Participants
Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
|
GT1 HCV 50-g Elbasvir (Panel B)
n=15 Participants
Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
GT1 HCV 5-mg Elbasvir (Panel C)
n=15 Participants
Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
|
Placebo
n=5 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
|
Placebo
n=8 Participants
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
|---|---|---|---|---|---|
|
Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
5-mg Elbasvir
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10-g Elbasvir
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50-mg Elbasvir
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100-mg Elbasvir
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Post-Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5-mg Elbasvir
n=5 participants at risk
Participants with HCV GT1 who received 5 -mg elbasvir
|
10-g Elbasvir
n=15 participants at risk
Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
|
50-mg Elbasvir
n=15 participants at risk
Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
|
100-mg Elbasvir
n=5 participants at risk
Participants with HCV GT3 who received 100-mg elbasvir
|
Placebo
n=8 participants at risk
Participants with HCV GT1, GT3 or GT1a who received placebo during.
|
Post-Study
n=48 participants at risk
All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
20.0%
1/5 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
12.5%
1/8 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
General disorders
Malaise
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
12.5%
1/8 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
General disorders
Thirst
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
12.5%
1/8 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Investigations
Blood pressure increased
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 2 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
26.7%
4/15 • Number of events 5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
33.3%
5/15 • Number of events 6 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
20.0%
1/5 • Number of events 3 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
37.5%
3/8 • Number of events 3 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
20.0%
1/5 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
6.7%
1/15 • Number of events 1 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/15 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/5 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/8 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
0.00%
0/48 • Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period
Adverse events are reported by drug taken at time of event for Days1-5 and not by panel or genotype. Adverse events for the post-study follow-up period (Days 6 to 61) are reported as 1 group regardless of genotype or study drug or dose received.
|
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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER