Trial Outcomes & Findings for A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039) (NCT NCT01716156)
NCT ID: NCT01716156
Last Updated: 2018-09-24
Results Overview
SVR12 was defined as HCV RNA \<25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to Week 36
Results posted on
2018-09-24
Participant Flow
A total of 26 treatment-naive non-cirrhotic adult participants with hepatitis C virus (HCV) genotype 1 (GT1) were recruited in Australia, Israel, and New Zealand.
Allocation of participants to the 2 arms was stratified according to HCV GT1a vs. GT1b infection. Participants in the 12-week arm with detectable HCV ribonucleic acid (RNA) at Treatment Week (TW) 4 received 12 additional weeks of study treatment and are displayed in a separate treatment arm.
Participant milestones
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 12 Weeks Plus Extended
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
13
|
|
Overall Study
COMPLETED
|
7
|
3
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 12 Weeks Plus Extended
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)
Baseline characteristics by cohort
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=9 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 12 Weeks Plus Extended
n=4 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=13 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
42.8 Years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 36Population: Per protocol population, as randomized. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
SVR12 was defined as HCV RNA \<25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=12 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=10 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
—
|
PRIMARY outcome
Timeframe: Fourteen days following last dose of study drug (up to 26 weeks)Population: The All Participants as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=11 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=15 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study
|
72.7 Percentage of participants
|
86.7 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: The APaT population included all randomized participants who received at least 1 dose of study therapy.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=11 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=15 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Discontinuing Study Therapy Due to an AE
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Full analysis set consists of all randomized participants receiving ≥1 dose of study therapy.
The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=12 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=14 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Time to Achievement of First Undetectable HCV RNA
|
27.1 Days
Standard Error 2.5
|
19.7 Days
Standard Error 2.8
|
—
|
SECONDARY outcome
Timeframe: From Week 2 through end of treatment (up to 24 weeks)Population: Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=8 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=4 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=12 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA by Time Point
Week 2
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
0.0 Percentage of participants
Interval 0.0 to 60.2
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
|
Percentage of Participants With Undetectable HCV RNA by Time Point
Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
0.0 Percentage of participants
Interval 0.0 to 60.2
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
|
Percentage of Participants With Undetectable HCV RNA by Time Point
Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
|
Percentage of Participants With Undetectable HCV RNA by Time Point
End of all therapy
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
SECONDARY outcome
Timeframe: From Week 2 through end of treatment (up to 24 weeks)Population: Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=8 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=4 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=12 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
Week 2
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
|
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
100.0 Percentage of participants
Interval 39.8 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
|
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
|
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
End of all therapy
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
SECONDARY outcome
Timeframe: Up to Week 28Population: Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA \<25 IU/mL 4 weeks after the end of all study therapy.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=8 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=4 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=11 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)
|
87.5 Percentage of participants
Interval 47.3 to 99.7
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA \<25 IU/mL 24 weeks after the end of all study therapy.
Outcome measures
| Measure |
Grazoprevir 100 mg + RBV 12 Weeks
n=8 Participants
Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=4 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
Grazoprevir 100 mg + RBV 24 Weeks
n=10 Participants
Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)
|
62.5 Percentage of participants
Interval 24.5 to 91.5
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
Adverse Events
Grazoprevir 100 mg + RBV: Beyond 12 Weeks
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Grazoprevir 100 mg + RBV: up to 12 Weeks
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Grazoprevir 100 mg + RBV: Beyond 12 Weeks
n=15 participants at risk
The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
|
Grazoprevir 100 mg + RBV: up to 12 Weeks
n=11 participants at risk
The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
3/15 • Number of events 4 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Number of events 4 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
18.2%
2/11 • Number of events 3 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 3 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
18.2%
2/11 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Asthenia
|
46.7%
7/15 • Number of events 7 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Irritability
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Psychiatric disorders
Affective disorder
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
18.2%
2/11 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
18.2%
2/11 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 6 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
36.4%
4/11 • Number of events 10 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
13.3%
2/15 • Number of events 2 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
0.00%
0/11 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
|
9.1%
1/11 • Number of events 1 • Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up)
APaT population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment 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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER