Trial Outcomes & Findings for Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype (NCT NCT01459913)
NCT ID: NCT01459913
Last Updated: 2015-06-10
Results Overview
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
239 participants
Primary outcome timeframe
12 weeks after last planned dose of study drug (up to Week 36)
Results posted on
2015-06-10
Participant Flow
Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.
Participant milestones
| Measure |
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus \[HCV\] Ribonucleic Acid \[RNA\] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
52
|
19
|
62
|
|
Overall Study
COMPLETED
|
65
|
32
|
6
|
29
|
|
Overall Study
NOT COMPLETED
|
41
|
20
|
13
|
33
|
Reasons for withdrawal
| Measure |
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus \[HCV\] Ribonucleic Acid \[RNA\] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
1
|
8
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Non- Compliance
|
0
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
30
|
15
|
9
|
11
|
|
Overall Study
Other
|
0
|
0
|
3
|
1
|
|
Overall Study
Did Not Meet Inclusion Criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
Baseline characteristics by cohort
| Measure |
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
n=19 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
n=61 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 12.89 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 10.56 • n=4 Participants
|
47.4 years
STANDARD_DEVIATION 12.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last planned dose of study drug (up to Week 36)Population: Full Analysis (FA) Set.
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
|
96.2 percentage of participants
|
88.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after last planned dose of study drug (up to Week 28)Population: FA Set.
SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
|
98.1 percentage of participants
|
89.6 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeks after last planned dose of study drug (up to Week 48)Population: FA Set.
SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
|
92.3 percentage of participants
|
85.8 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 72Population: FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to 'Study Terminated by the Sponsor' are excluded from this analysis.
SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=37 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=76 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
|
86.5 percentage of participants
|
72.4 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-upPopulation: FA Set.
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (\<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Viral Relapse
4 Weeks
|
0.0 percentage of participants
|
1.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Subjects With Viral Relapse
12 Weeks
|
0.0 percentage of participants
|
7.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Subjects With Viral Relapse
24 Weeks
|
0.0 percentage of participants
|
10.4 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: FA Set.
On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
n=19 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
n=61 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
n=238 Participants
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With On-Treatment Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: FA Set.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Rapid Viral Response (RVR)
|
52 participants
|
106 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: FA Set.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Extended Rapid Viral Response (eRVR)
|
51 participants
|
105 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: Safety set included all subjects who received at least 1 dose of study drug.
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.
Outcome measures
| Measure |
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
n=19 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
n=62 Participants
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, up to 48 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
51 participants
|
104 participants
|
19 participants
|
61 participants
|
—
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
4 participants
|
5 participants
|
3 participants
|
13 participants
|
—
|
Adverse Events
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Serious events: 5 serious events
Other events: 104 other events
Deaths: 0 deaths
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Serious events: 13 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
n=19 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
n=62 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
11.3%
7/62 • Baseline up to Week 48
|
|
General disorders
Asthenia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Chest pain
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Fatigue
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Pyrexia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Deep vein thrombosis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Hypotension
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Vascular disorders
Thrombosis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Syncope
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Anxiety
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Abscess oral
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Pneumonia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
Other adverse events
| Measure |
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
n=106 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
n=52 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
|
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
n=19 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
|
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
n=62 participants at risk
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
|
|---|---|---|---|---|
|
Investigations
Body temperature increased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Electrocardiogram QT prolonged
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Electrocardiogram ST-T change
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Eosinophil count increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Haematocrit decreased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Haemoglobin increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Lipase increased
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Liver function test abnormal
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Respiratory rate increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
4/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
General disorders
Fatigue
|
51.9%
55/106 • Baseline up to Week 48
|
48.1%
25/52 • Baseline up to Week 48
|
63.2%
12/19 • Baseline up to Week 48
|
41.9%
26/62 • Baseline up to Week 48
|
|
General disorders
Pyrexia
|
24.5%
26/106 • Baseline up to Week 48
|
25.0%
13/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
24.2%
15/62 • Baseline up to Week 48
|
|
General disorders
Influenza like illness
|
26.4%
28/106 • Baseline up to Week 48
|
19.2%
10/52 • Baseline up to Week 48
|
42.1%
8/19 • Baseline up to Week 48
|
14.5%
9/62 • Baseline up to Week 48
|
|
General disorders
Asthenia
|
13.2%
14/106 • Baseline up to Week 48
|
15.4%
8/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
21.0%
13/62 • Baseline up to Week 48
|
|
General disorders
Irritability
|
8.5%
9/106 • Baseline up to Week 48
|
13.5%
7/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
14.5%
9/62 • Baseline up to Week 48
|
|
General disorders
Chills
|
5.7%
6/106 • Baseline up to Week 48
|
11.5%
6/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
14.5%
9/62 • Baseline up to Week 48
|
|
General disorders
Injection site erythema
|
4.7%
5/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
General disorders
Pain
|
4.7%
5/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
General disorders
Malaise
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
8.1%
5/62 • Baseline up to Week 48
|
|
General disorders
Oedema peripheral
|
0.94%
1/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Chest pain
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Injection site reaction
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
General disorders
Injection site rash
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
General disorders
Chest discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Injection site pruritus
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Local swelling
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Thirst
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Feeling abnormal
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Injection site bruising
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Enanthema
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
General disorders
Feeling cold
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Feeling hot
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Injection site pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Non-cardiac chest pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
General disorders
Temperature intolerance
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Nausea
|
46.2%
49/106 • Baseline up to Week 48
|
36.5%
19/52 • Baseline up to Week 48
|
68.4%
13/19 • Baseline up to Week 48
|
53.2%
33/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
19/106 • Baseline up to Week 48
|
11.5%
6/52 • Baseline up to Week 48
|
31.6%
6/19 • Baseline up to Week 48
|
17.7%
11/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
17/106 • Baseline up to Week 48
|
11.5%
6/52 • Baseline up to Week 48
|
31.6%
6/19 • Baseline up to Week 48
|
17.7%
11/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Anorectal discomfort
|
20.8%
22/106 • Baseline up to Week 48
|
17.3%
9/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
8.1%
5/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Anal pruritus
|
9.4%
10/106 • Baseline up to Week 48
|
15.4%
8/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.5%
8/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
9.7%
6/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
5/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
11.3%
7/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
9/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Proctalgia
|
4.7%
5/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Constipation
|
3.8%
4/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
8.1%
5/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
3/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Cheilitis
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Haematochezia
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Toothache
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Oral pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Proctitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Retching
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Anal fissure
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Lip dry
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Lip pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Oral disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Perianal erythema
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Swollen tongue
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Tongue coated
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
41.5%
44/106 • Baseline up to Week 48
|
32.7%
17/52 • Baseline up to Week 48
|
42.1%
8/19 • Baseline up to Week 48
|
38.7%
24/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.2%
31/106 • Baseline up to Week 48
|
28.8%
15/52 • Baseline up to Week 48
|
47.4%
9/19 • Baseline up to Week 48
|
21.0%
13/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.3%
13/106 • Baseline up to Week 48
|
21.2%
11/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
11.3%
7/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
11/106 • Baseline up to Week 48
|
21.2%
11/52 • Baseline up to Week 48
|
31.6%
6/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.8%
4/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.7%
5/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.7%
5/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.8%
4/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Headache
|
28.3%
30/106 • Baseline up to Week 48
|
30.8%
16/52 • Baseline up to Week 48
|
26.3%
5/19 • Baseline up to Week 48
|
27.4%
17/62 • Baseline up to Week 48
|
|
Nervous system disorders
Dizziness
|
16.0%
17/106 • Baseline up to Week 48
|
11.5%
6/52 • Baseline up to Week 48
|
31.6%
6/19 • Baseline up to Week 48
|
22.6%
14/62 • Baseline up to Week 48
|
|
Nervous system disorders
Dysgeusia
|
12.3%
13/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
8.1%
5/62 • Baseline up to Week 48
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
2/106 • Baseline up to Week 48
|
9.6%
5/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Migraine
|
1.9%
2/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Disturbance in attention
|
2.8%
3/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Memory impairment
|
2.8%
3/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Hyperaesthesia
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Paraesthesia
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Somnolence
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Nervous system disorders
Syncope
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Lethargy
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Cognitive disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Dizziness exertional
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Drooling
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Neuropathy peripheral
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Nervous system disorders
Parosmia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Sciatica
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Nervous system disorders
Tremor
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Anaemia
|
39.6%
42/106 • Baseline up to Week 48
|
42.3%
22/52 • Baseline up to Week 48
|
52.6%
10/19 • Baseline up to Week 48
|
32.3%
20/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
5/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Insomnia
|
20.8%
22/106 • Baseline up to Week 48
|
21.2%
11/52 • Baseline up to Week 48
|
31.6%
6/19 • Baseline up to Week 48
|
19.4%
12/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Depression
|
11.3%
12/106 • Baseline up to Week 48
|
15.4%
8/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
16.1%
10/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Anxiety
|
5.7%
6/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Depressed mood
|
3.8%
4/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Mood swings
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Affect lability
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Agitation
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Anger
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Mood altered
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Sleep disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Apathy
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Drug dependence
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Emotional disorder
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Initial insomnia
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Nervousness
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Restlessness
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Aggression
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Loss of libido
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.0%
18/106 • Baseline up to Week 48
|
21.2%
11/52 • Baseline up to Week 48
|
26.3%
5/19 • Baseline up to Week 48
|
14.5%
9/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
9/106 • Baseline up to Week 48
|
9.6%
5/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
14.5%
9/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
7/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.7%
5/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
3/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
9/106 • Baseline up to Week 48
|
13.5%
7/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
12.9%
8/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
6/106 • Baseline up to Week 48
|
13.5%
7/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
17.7%
11/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
6/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
3/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
2/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Urinary tract infection
|
4.7%
5/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
2/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Infections and infestations
Pneumonia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Cellulitis
|
0.00%
0/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Ear infection
|
0.94%
1/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Oral herpes
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Cystitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Influenza
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Sinusitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Skin infection
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Bronchitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Candida infection
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Folliculitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Genital herpes
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Gingivitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Herpes pharyngitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Parotitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Rash pustular
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Rhinitis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Scrotal abscess
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Infections and infestations
Tooth infection
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.8%
21/106 • Baseline up to Week 48
|
11.5%
6/52 • Baseline up to Week 48
|
21.1%
4/19 • Baseline up to Week 48
|
16.1%
10/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Vision blurred
|
7.5%
8/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
15.8%
3/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Eye disorders
Photophobia
|
5.7%
6/106 • Baseline up to Week 48
|
5.8%
3/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Dry eye
|
3.8%
4/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Eye disorders
Eye pruritus
|
2.8%
3/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Ocular hyperaemia
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Eye disorders
Visual impairment
|
0.00%
0/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Diplopia
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Eye irritation
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Eye pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Retinal exudates
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Conjunctivitis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Retinal haemorrhage
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Retinopathy
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Weight decreased
|
7.5%
8/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
6.5%
4/62 • Baseline up to Week 48
|
|
Investigations
Lymphocyte count decreased
|
2.8%
3/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Blood uric acid increased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Investigations
Blood pressure increased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Haemoglobin decreased
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Platelet count decreased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Amylase increased
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Blood potassium decreased
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Blood urine present
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Transaminases increased
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
White blood cell count decreased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Investigations
Blood calcium decreased
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Investigations
Blood creatinine increased
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Ear pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Hypotension
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Vascular disorders
Pallor
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Vascular disorders
Hot flush
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Hypertension
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Orthostatic hypotension
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Vascular disorders
Haematoma
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Vascular disorders
Peripheral coldness
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Vascular disorders
Vascular pain
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Cardiac disorders
Palpitations
|
2.8%
3/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
10.5%
2/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
4.8%
3/62 • Baseline up to Week 48
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Contusion
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Laceration
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Scratch
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.9%
2/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/106 • Baseline up to Week 48
|
3.8%
2/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/106 • Baseline up to Week 48
|
7.7%
4/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Renal and urinary disorders
Urinary retention
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.94%
1/106 • Baseline up to Week 48
|
1.9%
1/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
5.3%
1/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
3.2%
2/62 • Baseline up to Week 48
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.94%
1/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
0.00%
0/62 • Baseline up to Week 48
|
|
Hepatobiliary disorders
Periportal oedema
|
0.00%
0/106 • Baseline up to Week 48
|
0.00%
0/52 • Baseline up to Week 48
|
0.00%
0/19 • Baseline up to Week 48
|
1.6%
1/62 • Baseline up to Week 48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER