Trial Outcomes & Findings for Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients (NCT NCT01016912)
NCT ID: NCT01016912
Last Updated: 2015-10-12
Results Overview
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
At Weeks 4 and 12 on treatment
Results posted on
2015-10-12
Participant Flow
The study was conducted at 6 sites in Japan.
A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.
Participant milestones
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders)
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
End of Treatment Period
STARTED
|
8
|
9
|
10
|
9
|
9
|
|
End of Treatment Period
Received Treatment
|
8
|
9
|
10
|
9
|
9
|
|
End of Treatment Period
COMPLETED
|
8
|
6
|
9
|
5
|
5
|
|
End of Treatment Period
NOT COMPLETED
|
0
|
3
|
1
|
4
|
4
|
|
Follow-up Period
STARTED
|
8
|
9
|
10
|
9
|
9
|
|
Follow-up Period
COMPLETED
|
8
|
9
|
9
|
8
|
9
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders)
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
End of Treatment Period
Lack of Efficacy
|
0
|
1
|
0
|
4
|
4
|
|
End of Treatment Period
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
End of Treatment Period
Completed double-blind period only
|
0
|
1
|
0
|
0
|
0
|
|
Follow-up Period
Other reason
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Baseline characteristics by cohort
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 15.09 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 6.11 • n=4 Participants
|
58.8 years
STANDARD_DEVIATION 9.46 • n=21 Participants
|
54.2 years
STANDARD_DEVIATION 10.46 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At Weeks 4 and 12 on treatmentPopulation: All participants who received at least 1 dose of study therapy.
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
|
0 percentage of participants
Interval 0.0 to 25.0
|
66.7 percentage of participants
Interval 40.1 to 87.1
|
80.0 percentage of participants
Interval 55.0 to 94.5
|
55.6 percentage of participants
Interval 30.1 to 79.0
|
22.2 percentage of participants
Interval 6.1 to 49.0
|
SECONDARY outcome
Timeframe: At Week 4 on treatmentPopulation: All participants who received at least 1 dose of study therapy.
RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
0 percentage of participants
Interval 0.0 to 25.0
|
77.8 percentage of participants
Interval 51.0 to 93.9
|
80.0 percentage of participants
Interval 55.0 to 94.5
|
55.6 percentage of participants
Interval 30.1 to 79.0
|
33.3 percentage of participants
Interval 12.9 to 59.9
|
SECONDARY outcome
Timeframe: At Week 12 on treatmentPopulation: All participants who received at least 1 dose of study therapy.
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR)
|
62.5 percentage of participants
Interval 34.5 to 85.3
|
77.8 percentage of participants
Interval 51.0 to 93.9
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
55.6 percentage of participants
Interval 30.1 to 79.0
|
55.6 percentage of participants
Interval 30.1 to 79.0
|
SECONDARY outcome
Timeframe: Follow-up Weeks 4, 12, and 24Population: All participants who received at least 1 dose of study therapy.
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR12: Follow-up Week 12
|
62.5 percentage of participants
Interval 34.5 to 85.3
|
66.7 percentage of participants
Interval 40.1 to 87.1
|
90.0 percentage of participants
Interval 66.3 to 99.0
|
22.2 percentage of participants
Interval 6.1 to 49.0
|
33.3 percentage of participants
Interval 12.9 to 59.9
|
|
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR24: Follow-up Week 24
|
62.5 percentage of participants
Interval 34.5 to 85.3
|
66.7 percentage of participants
Interval 40.1 to 87.1
|
90.0 percentage of participants
Interval 66.3 to 99.0
|
22.2 percentage of participants
Interval 6.1 to 49.0
|
33.3 percentage of participants
Interval 12.9 to 59.9
|
|
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR4: Follow-up Week 4
|
75.0 percentage of participants
Interval 46.2 to 93.1
|
66.7 percentage of participants
Interval 40.1 to 87.1
|
90.0 percentage of participants
Interval 66.3 to 99.0
|
22.2 percentage of participants
Interval 6.1 to 49.0
|
33.3 percentage of participants
Interval 12.9 to 59.9
|
SECONDARY outcome
Timeframe: From on-treatment Week 1 to Follow-up Week 24Population: All participants who received at least 1 dose of study therapy.
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
Virologic failure
|
37.5 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
77.8 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic breakthrough
|
12.5 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
44.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Relapse
|
25.0 percentage of participants
|
11.1 percentage of participants
|
10.0 percentage of participants
|
33.3 percentage of participants
|
22.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 30 days after last dose of study drugPopulation: All participants who received at least 1 dose of study therapy.
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.
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
SAEs
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
Discontinuation due to AEs
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
Treatment-related AEs
|
8 participants
|
9 participants
|
10 participants
|
9 participants
|
9 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 30 days after last dose of study drugPopulation: All participants who received at least 1 dose of study therapy.
Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= \<7.0 to 8.9 g/dL, Grade 4= \<7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm\^3, Grade 4= \<350 cells/mm\^3. Neutrophils: Grade 3= 500-999 cells/mm\^3, Grade 4= \<500 cells/mm\^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm\^3, Grade 4= \<1000 cells/mm\^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10\*upper limit of normal (ULN), Grade 4= \>10.0\*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10\*ULN, Grade 4= \>10.0\*ULN. Total bilirubin: Grade 3= 2.6-5\*ULN, Grade 4= \>5.0\*ULN.
Outcome measures
| Measure |
Placebo + pegIFNα + Ribavirin (Treatment-naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)
n=10 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
|
Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)
n=9 Participants
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)
n=9 Participants
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Hemoglobin
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Lymphocytes
|
2 participants
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Neutrophils
|
2 participants
|
4 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
WBC
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
ALT
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
AST
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Total bilirubin
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo+pegIFNα +Ribavirin (Treatment Naive)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+pegIFNα +Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)
n=9 participants at risk
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)
n=10 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)
n=9 participants at risk
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
|
Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)
n=9 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
Other adverse events
| Measure |
Placebo+pegIFNα +Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)
n=9 participants at risk
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)
n=10 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
|
Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)
n=9 participants at risk
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
|
Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)
n=9 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
50.0%
5/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Blepharitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Blood thyroid stimulating hormone increased
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Fatigue
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Feeling abnormal
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Injection site rash
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
44.4%
4/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Retinal tear
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Retinopathy
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Psychiatric disorders
Depressed mood
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
40.0%
4/10 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Folliculitis
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Weight decreased
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Injection site reaction
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Retinal disorder
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
62.5%
5/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Chills
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Phosphenes
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Vessel puncture site reaction
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Chest pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Injection site injury
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Pyrexia
|
62.5%
5/8 • From baseline up to 30 days after last dose of study drug
|
88.9%
8/9 • From baseline up to 30 days after last dose of study drug
|
90.0%
9/10 • From baseline up to 30 days after last dose of study drug
|
66.7%
6/9 • From baseline up to 30 days after last dose of study drug
|
88.9%
8/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Enterocolitis
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Injection site erythema
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Lip dry
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Eye disorders
Retinal exudates
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
3/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
70.0%
7/10 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Blood pressure increased
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Nervous system disorders
Headache
|
62.5%
5/8 • From baseline up to 30 days after last dose of study drug
|
66.7%
6/9 • From baseline up to 30 days after last dose of study drug
|
40.0%
4/10 • From baseline up to 30 days after last dose of study drug
|
55.6%
5/9 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Injection site pruritus
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
33.3%
3/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
30.0%
3/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Investigations
Lipase increased
|
12.5%
1/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Malaise
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
77.8%
7/9 • From baseline up to 30 days after last dose of study drug
|
20.0%
2/10 • From baseline up to 30 days after last dose of study drug
|
22.2%
2/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
11.1%
1/9 • From baseline up to 30 days after last dose of study drug
|
|
General disorders
Vessel puncture site pruritus
|
0.00%
0/8 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
10.0%
1/10 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
0.00%
0/9 • From baseline up to 30 days after last dose of study drug
|
Additional Information
BristolMyers Squibb Study Director
Bristol-Myers Squibb International Corporation
Email: [email protected]
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