Trial Outcomes & Findings for Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047) (NCT NCT01932762)
NCT ID: NCT01932762
Last Updated: 2021-02-04
Results Overview
SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \<25 IU/mL, either target detected but unquantifiable (TD\[u\]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
12 weeks after end of all therapy (Study Week 24)
Results posted on
2021-02-04
Participant Flow
98 participants were assigned to treatment at 28 sites worldwide and all enrolled participants received ≥1 dose of study therapy. 30 participants enrolled in Part A and 68 were enrolled and randomized in Part B of the study. Enrollment in Part C, an evaluation of a fixed-dose combination of grazoprevir and elbasvir, was never initiated.
Participant milestones
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
19
|
19
|
|
Overall Study
COMPLETED
|
24
|
28
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)
Baseline characteristics by cohort
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=30 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=30 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=19 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=19 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
48.3 years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
52.2 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
52.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 13.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after end of all therapy (Study Week 24)Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.
SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \<25 IU/mL, either target detected but unquantifiable (TD\[u\]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=27 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=24 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=17 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=13 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)
|
85.2 percentage of participants
Interval 66.3 to 95.8
|
75.0 percentage of participants
Interval 53.3 to 90.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
PRIMARY outcome
Timeframe: Treatment period plus the first 14 days of follow-up (up to 14 weeks)Population: All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=30 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=30 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=19 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=19 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
AEs
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
SAEs
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
Drug-related AE
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
57.9 percentage of participants
Interval 33.5 to 79.7
|
36.8 percentage of participants
Interval 16.3 to 61.6
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
Drug-related SAE
|
0.0 percentage of participants
Interval 0.0 to 11.6
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
Discontinuation due to AE
|
0.0 percentage of participants
Interval 0.0 to 11.6
|
0.0 percentage of participants
Interval 0.0 to 11.6
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
5.3 percentage of participants
Interval 0.1 to 26.0
|
SECONDARY outcome
Timeframe: From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)Population: FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=30 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=26 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=19 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=18 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Mean Time to First Achievement of Undetectable HCV RNA During Treatment
|
25.2 days
Standard Error 2.8
|
26.9 days
Standard Error 3.0
|
27.4 days
Standard Error 4.5
|
21.3 days
Standard Error 1.7
|
SECONDARY outcome
Timeframe: From TW 2 through TW 12 (up to 12 weeks)Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=28 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=24 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=17 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=15 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint
Week 2 (n=28, 24, 16, 15)
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
50.0 percentage of participants
Interval 29.1 to 70.9
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint
Week 4 (n=28, 24, 17, 15)
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
80.0 percentage of participants
Interval 51.9 to 95.7
|
|
Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint
Week 12 (n=28, 24, 17, 14)
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
83.3 percentage of participants
Interval 62.6 to 95.3
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
SECONDARY outcome
Timeframe: From TW 2 through TW 12 (up to 12 weeks)Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels \<25 IU/ml (either TD\[u\] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=28 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=24 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=17 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=15 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint
Week 2 (n=28, 24, 16, 15)
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint
Week 4 (n=28, 24, 17, 15)
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint
Week 12 (n=28, 24, 17, 14)
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
85.7 percentage of participants
Interval 57.2 to 98.2
|
SECONDARY outcome
Timeframe: 4 weeks after end of all therapy (Study Week 16)Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
SVR4 was defined as HCV RNA \<25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=27 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=24 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=17 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=14 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SVR4
|
88.9 percentage of participants
Interval 70.8 to 97.6
|
83.3 percentage of participants
Interval 62.6 to 95.3
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
SECONDARY outcome
Timeframe: 24 weeks after end of all therapy (Study Week 36)Population: All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.
SVR24 was defined as HCV RNA \<25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.
Outcome measures
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=26 Participants
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=24 Participants
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=17 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=13 Participants
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SVR24
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
75.0 percentage of participants
Interval 53.3 to 90.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
Adverse Events
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
GT2: Grazoprevir + RBV (Arm B1)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=30 participants at risk
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=30 participants at risk
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=19 participants at risk
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=19 participants at risk
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Renal and urinary disorders
Renal failure acute
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Vascular disorders
Flushing
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
Other adverse events
| Measure |
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)
n=30 participants at risk
During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT2: Grazoprevir + RBV (Arm B1)
n=30 participants at risk
During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)
n=19 participants at risk
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
|
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)
n=19 participants at risk
During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Skin infection
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Viral infection
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
13.3%
4/30 • Number of events 7 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
13.3%
4/30 • Number of events 6 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Stomatitis
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
5/30 • Number of events 6 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Asthenia
|
16.7%
5/30 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
20.0%
6/30 • Number of events 6 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
21.1%
4/19 • Number of events 4 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Fatigue
|
40.0%
12/30 • Number of events 13 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
20.0%
6/30 • Number of events 7 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
26.3%
5/19 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Feeling cold
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Influenza like illness
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Pyrexia
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
General disorders
Thirst
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Bronchitis
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Influenza
|
10.0%
3/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Infections and infestations
Oral herpes
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
4/30 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
2/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
21.1%
4/19 • Number of events 4 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
13.3%
4/30 • Number of events 6 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.0%
3/30 • Number of events 4 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 9 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Disturbance in attention
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • Number of events 8 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 8 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
13.3%
4/30 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
31.6%
6/19 • Number of events 8 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
26.3%
5/19 • Number of events 20 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Poor quality sleep
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Psychiatric disorders
Depressed mood
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Psychiatric disorders
Irritability
|
10.0%
3/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Reproductive system and breast disorders
Genital tract inflammation
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
5/30 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
21.1%
4/19 • Number of events 4 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
21.1%
4/19 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
4/30 • Number of events 4 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
3/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
10.5%
2/19 • Number of events 3 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
6.7%
2/30 • Number of events 2 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
15.8%
3/19 • Number of events 5 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/30 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
0.00%
0/19 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
5.3%
1/19 • Number of events 1 • From TW1 through FW 24 (up to 36 weeks)
AEs were reported for the ASAT Population (all randomized participants who received ≥1 dose of study therapy) for both the treatment and follow-up periods.
|
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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER