Trial Outcomes & Findings for Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection (NCT NCT01257204)
NCT ID: NCT01257204
Last Updated: 2015-12-14
Results Overview
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
196 participants
Primary outcome timeframe
Follow-up Week 24
Results posted on
2015-12-14
Participant Flow
A total of 196 participants were enrolled, of which 152 participants were randomized; remaining 44 participants did not meet study criteria. Of randomized participants:151 were treated; 1 participant withdrew consent.
Participant milestones
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
|
Placebo
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
|
|---|---|---|---|
|
Treatment Period (up to Week 24)
STARTED
|
50
|
50
|
51
|
|
Treatment Period (up to Week 24)
COMPLETED
|
45
|
44
|
42
|
|
Treatment Period (up to Week 24)
NOT COMPLETED
|
5
|
6
|
9
|
|
Follow-up Period (up to Week 48)
STARTED
|
49
|
47
|
49
|
|
Follow-up Period (up to Week 48)
COMPLETED
|
48
|
41
|
39
|
|
Follow-up Period (up to Week 48)
NOT COMPLETED
|
1
|
6
|
10
|
Reasons for withdrawal
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
|
Placebo
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
|
|---|---|---|---|
|
Treatment Period (up to Week 24)
Lack of Efficacy
|
0
|
1
|
3
|
|
Treatment Period (up to Week 24)
Adverse Event
|
3
|
1
|
2
|
|
Treatment Period (up to Week 24)
Withdrawal by Subject
|
1
|
0
|
1
|
|
Treatment Period (up to Week 24)
Lost to Follow-up
|
0
|
2
|
0
|
|
Treatment Period (up to Week 24)
Poor compliance/noncompliance
|
0
|
0
|
1
|
|
Treatment Period (up to Week 24)
Participant's request to discontinue
|
1
|
2
|
2
|
|
Follow-up Period (up to Week 48)
Withdrawal by Subject
|
0
|
2
|
1
|
|
Follow-up Period (up to Week 48)
Lost to Follow-up
|
1
|
4
|
4
|
|
Follow-up Period (up to Week 48)
Other
|
0
|
0
|
5
|
Baseline Characteristics
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Baseline characteristics by cohort
| Measure |
Dacalatasvir, 60 mg, 12-Week Cohort
n=50 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=50 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=51 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 9.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Hepatitis C Virus (HCV) RNA (IU/mL)
|
6.4 Log10 IU/mL
STANDARD_DEVIATION 0.82 • n=5 Participants
|
6.6 Log10 IU/mL
STANDARD_DEVIATION 0.62 • n=7 Participants
|
6.6 Log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.5 Log10 IU/mL
STANDARD_DEVIATION 0.69 • n=4 Participants
|
|
HCV RNA Distribution
<800,000 IU/mL
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
HCV RNA Distribution
≥800,000 IU/mL
|
38 participants
n=5 Participants
|
43 participants
n=7 Participants
|
45 participants
n=5 Participants
|
126 participants
n=4 Participants
|
|
Randomization Stratum
HCV Genotype 2
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
24 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Randomization Stratum
HCV Genotype 3
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Cirrhosis Status
Absent
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
41 participants
n=5 Participants
|
127 participants
n=4 Participants
|
|
Cirrhosis Status
Present
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Cirrhosis Status
Not Reported
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 24Population: All treated participants with hepatitis C virus genotype 2.
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=24 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=23 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=24 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
|
83.3 percentage of participants
Interval 73.6 to 93.1
|
82.6 percentage of participants
Interval 72.5 to 92.7
|
62.5 percentage of participants
Interval 49.8 to 75.2
|
PRIMARY outcome
Timeframe: Follow-up Week 24Population: All treated participants with HCV genotype 3.
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=26 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=27 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=27 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
|
69.2 percentage of participants
Interval 57.6 to 80.8
|
66.7 percentage of participants
Interval 55.0 to 78.3
|
59.3 percentage of participants
Interval 47.1 to 71.4
|
SECONDARY outcome
Timeframe: Week 4Population: All treated participants with HCV genotype 2.
RVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=24 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=23 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=24 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
|
87.5 percentage of participants
Interval 78.8 to 96.2
|
73.9 percentage of participants
Interval 62.2 to 85.6
|
41.7 percentage of participants
Interval 28.8 to 54.6
|
SECONDARY outcome
Timeframe: Week 4Population: All treated participants with HCV genotype 3.
RVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=26 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=27 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=27 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
|
84.6 percentage of participants
Interval 75.5 to 93.7
|
74.1 percentage of participants
Interval 63.3 to 84.9
|
37.0 percentage of participants
Interval 25.1 to 48.9
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants with HCV genotype 2.
cEVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=24 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=23 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=24 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
|
91.7 percentage of participants
Interval 84.4 to 98.9
|
82.6 percentage of participants
Interval 72.5 to 92.7
|
75.0 percentage of participants
Interval 63.7 to 86.3
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants with HCV genotype 3.
cEVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=26 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=27 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=27 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
|
80.8 percentage of participants
Interval 70.9 to 90.7
|
88.9 percentage of participants
Interval 81.1 to 96.6
|
59.3 percentage of participants
Interval 47.1 to 71.4
|
SECONDARY outcome
Timeframe: Follow-up Week 12Population: All treated participants with HCV genotype 2.
SVR12 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=24 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=23 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=24 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
|
87.5 percentage of participants
Interval 78.8 to 96.2
|
82.6 percentage of participants
Interval 72.5 to 92.7
|
70.8 percentage of participants
Interval 58.9 to 82.7
|
SECONDARY outcome
Timeframe: Follow-up Week 12Population: All treated participants with HCV genotype 3.
SVR12 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=26 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=27 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=27 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
|
69.2 percentage of participants
Interval 57.6 to 80.8
|
77.8 percentage of participants
Interval 67.5 to 88.0
|
51.9 percentage of participants
Interval 39.5 to 64.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: All treated participants with HCV genotype 2. Here, "n" signifies the number of participants evaluable for the respective category.
Virologic failure was defined as: 1. Virologic breakthrough: confirmed \>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment 3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment 4. HCV RNA ≥LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation) 5. Relapse, defined as HCV RNA ≥LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \<LLOQ, TND at EOT. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=24 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=23 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=24 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Virologic breakthrough (n=24,23,24)
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
<1 log10 decrease in HCV RNA at Week4 (n=24,23,24)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=24,23,24)
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Relapse (n=23,21,22)
|
1 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: All treated participants with HCV genotype 3. Here, "n" signifies the number of participants evaluable for the respective category.
Virologic failure was defined as: 1. Virologic breakthrough: confirmed \>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment 3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment 4. HCV RNA ≥LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation) 5. Relapse, defined as HCV RNA ≥LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \<LLOQ, TND at EOT. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=26 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=27 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=27 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Virologic breakthrough (n=26,27,27)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
<1 log10 decrease in HCV RNA at Week4 (n=26,27,27)
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=26,27,27)
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Relapse (n=25,24,21)
|
6 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to 24 weeks (treatment period)Population: All treated participants.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=50 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=50 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=51 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
AEs
|
49 participants
|
49 participants
|
50 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
SAEs
|
4 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
Discontinuations due to AEs
|
4 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
Grade 2-4 Treatment-related AEs
|
27 participants
|
22 participants
|
30 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
Deaths
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From end of treatment period up to Week 48 (follow-up period)Population: All follow-up participants.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Outcome measures
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=49 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=47 Participants
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
|
Placebo
n=49 Participants
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AEs
|
16 participants
|
12 participants
|
11 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
SAEs
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Deaths
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Daclatasvir, 60 mg, 12-Week Cohort
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Daclatasvir, 60 mg, 16-Week Cohort
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo: Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=50 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=50 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
|
Placebo
n=51 participants at risk
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
|
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up
n=49 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
|
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up
n=47 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
|
Placebo: Follow-up
n=49 participants at risk
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Hepatobiliary disorders
Biliary colic
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Adhesion
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
Other adverse events
| Measure |
Daclatasvir, 60 mg, 12-Week Cohort
n=50 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
|
Daclatasvir, 60 mg, 16-Week Cohort
n=50 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
|
Placebo
n=51 participants at risk
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
|
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up
n=49 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
|
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up
n=47 participants at risk
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
|
Placebo: Follow-up
n=49 participants at risk
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Disturbance in attention
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
7/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
15.7%
8/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.0%
9/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
21.6%
11/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Sleep disorder
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
3.9%
2/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
14.0%
7/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
11.8%
6/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
3.9%
2/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.0%
14/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
26.0%
13/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
27.5%
14/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
11.8%
6/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
3.9%
2/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
7.8%
4/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
15.7%
8/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Influenza like illness
|
20.0%
10/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
18.0%
9/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
13.7%
7/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Injection site reaction
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
7.8%
4/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Asthenia
|
12.0%
6/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
14.0%
7/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
13.7%
7/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Depression
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
14.0%
7/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
17.6%
9/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Fatigue
|
46.0%
23/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
24.0%
12/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
37.3%
19/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Injection site erythema
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Insomnia
|
22.0%
11/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
16.0%
8/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
33.3%
17/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
7.8%
4/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
7/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
9.8%
5/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
9.8%
5/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Anxiety
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
7.8%
4/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
12.0%
6/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
17.6%
9/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Chills
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Irritability
|
16.0%
8/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
18.0%
9/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
11.8%
6/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Nervous system disorders
Memory impairment
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
5.9%
3/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Gastrointestinal disorders
Nausea
|
20.0%
10/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
24.0%
12/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
15.7%
8/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
General disorders
Pyrexia
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
3.9%
2/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
4/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
16.0%
8/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
15.7%
8/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
22.0%
11/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
11.8%
6/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Nervous system disorders
Headache
|
30.0%
15/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
30.0%
15/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
17.6%
9/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Psychiatric disorders
Mood swings
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.0%
13/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
24.0%
12/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
23.5%
12/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Eye disorders
Vision blurred
|
6.0%
3/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
2.0%
1/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
3.9%
2/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
4.0%
2/50 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
11.8%
6/51 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/47 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
0.00%
0/49 • Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER