Trial Outcomes & Findings for Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058) (NCT NCT02203149)
NCT ID: NCT02203149
Last Updated: 2018-09-24
Results Overview
An 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 unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
399 participants
Primary outcome timeframe
Up to Study Week 12 in Part 2
Results posted on
2018-09-24
Participant Flow
Of 432 screened, 63 were enrolled and randomized to Part 1 and 336 were enrolled and randomized to Part 2, for a total of 399 randomized.
Participant milestones
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1
STARTED
|
31
|
32
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
31
|
31
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
227
|
74
|
35
|
|
Part 2
Started Deferred Active Treatment
|
0
|
0
|
0
|
73
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
226
|
71
|
34
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Part 2
Death
|
0
|
0
|
1
|
1
|
0
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
Baseline characteristics by cohort
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=32 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=227 Participants
Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
n=74 Participants
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
n=35 Participants
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
58.0 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
60.9 years
STANDARD_DEVIATION 10.8 • n=483 Participants
|
64.8 years
STANDARD_DEVIATION 9.2 • n=36 Participants
|
61.1 years
STANDARD_DEVIATION 11.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
246 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
153 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)Population: The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=149 Participants
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)
|
—
|
—
|
96.6 percentage of participants
Interval 92.3 to 98.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)Population: All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.
An 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 unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks
|
67.7 percentage of participants
|
74.2 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Study Week 12 in Part 1Population: All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.
An 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 unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants That Discontinued Treatment Due to an AE
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)Population: All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.
An 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 unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=227 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=74 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=35 Participants
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks
|
64.8 percentage of participants
|
67.6 percentage of participants
|
80.0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Study Week 12 in Part 2Population: All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.
An 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 unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=227 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=74 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=35 Participants
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE
|
1.3 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24Population: All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
TW2
|
22.6 percentage of participants
Interval 9.6 to 41.1
|
35.5 percentage of participants
Interval 19.2 to 54.6
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
TW4
|
77.4 percentage of participants
Interval 58.9 to 90.4
|
83.9 percentage of participants
Interval 66.3 to 94.5
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
TW12
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
EOT
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
FUWK4
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
FUWK12
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
FUWK24
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24Population: All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
TW2
|
61.3 percentage of participants
Interval 42.2 to 78.2
|
71.0 percentage of participants
Interval 52.0 to 85.8
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
TW4
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
TW12
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
EOT
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
FUWK4
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
FUWK12
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
FUWK24
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24Population: All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=227 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=73 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=35 Participants
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
TW2
|
25.1 percentage of participants
Interval 19.6 to 31.3
|
39.7 percentage of participants
Interval 28.5 to 51.9
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
TW4
|
70.5 percentage of participants
Interval 64.1 to 76.3
|
86.3 percentage of participants
Interval 76.2 to 93.2
|
65.7 percentage of participants
Interval 47.8 to 80.9
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
TW12
|
97.8 percentage of participants
Interval 94.9 to 99.3
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
EOT
|
98.7 percentage of participants
Interval 96.2 to 99.7
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
FUWK4
|
98.2 percentage of participants
Interval 95.5 to 99.5
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
FUWK12
|
96.5 percentage of participants
Interval 93.2 to 98.5
|
95.9 percentage of participants
Interval 88.5 to 99.1
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
FUWK24
|
96.5 percentage of participants
Interval 93.2 to 98.5
|
95.9 percentage of participants
Interval 88.5 to 99.1
|
94.3 percentage of participants
Interval 80.8 to 99.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24Population: All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
Outcome measures
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=227 Participants
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=73 Participants
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=35 Participants
Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
TW2
|
60.8 percentage of participants
Interval 54.1 to 67.2
|
69.9 percentage of participants
Interval 58.0 to 80.1
|
60.0 percentage of participants
Interval 42.1 to 76.1
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
TW4
|
96.0 percentage of participants
Interval 92.6 to 98.2
|
98.6 percentage of participants
Interval 92.6 to 100.0
|
94.3 percentage of participants
Interval 80.8 to 99.3
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
TW12
|
98.7 percentage of participants
Interval 96.2 to 99.7
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
EOT
|
99.6 percentage of participants
Interval 97.6 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
FUWK4
|
98.2 percentage of participants
Interval 95.5 to 99.5
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
FUWK12
|
96.5 percentage of participants
Interval 93.2 to 98.5
|
97.3 percentage of participants
Interval 90.5 to 99.7
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
—
|
—
|
|
Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
FUWK24
|
96.5 percentage of participants
Interval 93.2 to 98.5
|
95.9 percentage of participants
Interval 88.5 to 99.1
|
97.1 percentage of participants
Interval 85.1 to 99.9
|
—
|
—
|
Adverse Events
Part 1 Grazoprevir 50 mg + Elbasvir
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 1 Grazoprevir 100 mg + Elbasvir
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
Serious events: 19 serious events
Other events: 109 other events
Deaths: 0 deaths
Part 2 Non-cirrhotic Deferred: Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Part 2 Cirrhotic: Grazoprevir + Elbasvir
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 participants at risk
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 participants at risk
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=227 participants at risk
Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
n=74 participants at risk
Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir
n=73 participants at risk
During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
n=35 participants at risk
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Eye disorders
Cataract
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.3%
3/227 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/73 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/73 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Infections and infestations
Appendicitis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Nervous system disorders
Sciatica
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
General disorders
Lead dislodgement
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
Other adverse events
| Measure |
Part 1 Grazoprevir 50 mg + Elbasvir
n=31 participants at risk
Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 1 Grazoprevir 100 mg + Elbasvir
n=31 participants at risk
Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
|
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
n=227 participants at risk
Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
Part 2 Non-cirrhotic Deferred: Placebo
n=74 participants at risk
Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
|
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir
n=73 participants at risk
During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
|
Part 2 Cirrhotic: Grazoprevir + Elbasvir
n=35 participants at risk
Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/73 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Eye disorders
Conjunctival haemorrhage
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.3%
3/227 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Eye disorders
Dry eye
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.88%
2/227 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.6%
6/227 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/73 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.8%
11/227 • Number of events 11 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/74 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.5%
4/73 • Number of events 4 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
8.6%
3/35 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.3%
12/227 • Number of events 14 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/74 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
8.2%
6/73 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
8.6%
3/35 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.88%
2/227 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/73 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
General disorders
Malaise
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.1%
7/227 • Number of events 7 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/74 • Number of events 5 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
6.8%
5/73 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
General disorders
Pyrexia
|
9.7%
3/31 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.3%
3/227 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/73 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Infections and infestations
Cystitis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.5%
8/227 • Number of events 9 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
8.2%
6/73 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Infections and infestations
Nasopharyngitis
|
25.8%
8/31 • Number of events 12 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
35.5%
11/31 • Number of events 12 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
20.7%
47/227 • Number of events 56 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
16.2%
12/74 • Number of events 18 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
27.4%
20/73 • Number of events 25 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
22.9%
8/35 • Number of events 11 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Infections and infestations
Periodontitis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/73 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.2%
5/227 • Number of events 5 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/73 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/35 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.5%
2/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.44%
1/227 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.3%
12/227 • Number of events 12 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/73 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
14.3%
5/35 • Number of events 5 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.4%
10/227 • Number of events 10 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/74 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/73 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
17.1%
6/35 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Blood creatine phosphokinase increased
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.1%
7/227 • Number of events 7 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.4%
4/74 • Number of events 4 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.1%
3/73 • Number of events 4 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.9%
1/35 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Investigations
Protein urine present
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/227 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
3.5%
8/227 • Number of events 8 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/73 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Number of events 6 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
9.7%
3/31 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.8%
11/227 • Number of events 13 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/74 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
2.7%
2/73 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.88%
2/227 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/74 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
5.7%
2/35 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31 • Number of events 2 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/31 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
4.0%
9/227 • Number of events 10 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
1.4%
1/74 • Number of events 1 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
0.00%
0/73 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
8.6%
3/35 • Number of events 3 • Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks
All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0
|
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 investigator or sub-investigators may publicly present the academic accomplishment acquired from the Study at a specialized academic meeting or research conference. The Sponsor may freely use the information acquired from the Study for the purpose of marketing authorization application of the test drug.
- Publication restrictions are in place
Restriction type: OTHER