Trial Outcomes & Findings for Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (NCT NCT02577029)
NCT ID: NCT02577029
Last Updated: 2026-01-13
Results Overview
The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Baseline, Week 60
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
Cohort 1
Treatment-naïve, hepatitis B "e" antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous \[IV\]) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered entecavir (ETV) or tenofovir (TDF) for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 4
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
7
|
12
|
11
|
13
|
12
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
7
|
12
|
11
|
13
|
12
|
12
|
Reasons for withdrawal
| Measure |
Cohort 1
Treatment-naïve, hepatitis B "e" antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous \[IV\]) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered entecavir (ETV) or tenofovir (TDF) for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 4
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Termination of the Study
|
9
|
2
|
5
|
12
|
10
|
12
|
12
|
12
|
Baseline Characteristics
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
n=2 Participants
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
n=7 Participants
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 4
n=12 Participants
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
n=11 Participants
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
n=13 Participants
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
n=12 Participants
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
n=12 Participants
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 11.09 • n=210 Participants
|
29.5 years
STANDARD_DEVIATION 0.71 • n=19 Participants
|
40.4 years
STANDARD_DEVIATION 7.37 • n=123 Participants
|
36.3 years
STANDARD_DEVIATION 9.32 • n=123 Participants
|
39.6 years
STANDARD_DEVIATION 12.61 • n=615 Participants
|
38.2 years
STANDARD_DEVIATION 7.97 • n=20 Participants
|
39.6 years
STANDARD_DEVIATION 7.73 • n=13 Participants
|
36.7 years
STANDARD_DEVIATION 7.32 • n=335 Participants
|
37.4 years
STANDARD_DEVIATION 9.17 • n=451 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=123 Participants
|
6 Participants
n=123 Participants
|
3 Participants
n=615 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=13 Participants
|
5 Participants
n=335 Participants
|
34 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
6 Participants
n=123 Participants
|
8 Participants
n=615 Participants
|
11 Participants
n=20 Participants
|
6 Participants
n=13 Participants
|
7 Participants
n=335 Participants
|
45 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 60Population: The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.
The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-upThe Principal Investigator (or medically qualified designee) will use clinical judgment to determine the relationship. An adverse event (AE) was considered "possibly related" when there is a reasonable possibility that the incident, experience, or outcome may have been caused by the product under investigation. An AE was considered "probably related" when there are facts, evidence, or arguments to suggest that the event is related to the product under investigation. Only AEs that occurred post-dose were considered treatment-emergent. Clinically significant abnormal laboratory findings or other abnormal assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs.
Outcome measures
| Measure |
Cohort 4
n=12 Participants
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
n=11 Participants
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 1
n=10 Participants
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
n=2 Participants
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
n=7 Participants
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
n=13 Participants
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
n=12 Participants
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
n=12 Participants
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment
Related TEAE
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment
Related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
The qualitative HBsAg assay gives a binary result, positive or negative.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 96Population: This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 96Population: This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 52Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
Resistance is defined as \> 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 60Population: The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.
Resistance is defined as \> 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 60, 72 and 96Population: The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 6
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 8
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
n=2 participants at risk
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
n=7 participants at risk
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 4
n=12 participants at risk
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
n=11 participants at risk
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
n=13 participants at risk
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
n=12 participants at risk
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
n=12 participants at risk
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (2 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
Cohort 2
n=2 participants at risk
Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 3
n=7 participants at risk
Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 4
n=12 participants at risk
Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 5
n=11 participants at risk
Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 6
n=13 participants at risk
Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.
|
Cohort 7
n=12 participants at risk
Treatment-naïve, HBeAg-negative or HBeAg-positive participants with HDV administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.
|
Cohort 8
n=12 participants at risk
Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
16.7%
2/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
41.7%
5/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
23.1%
3/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Administration site bruise
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Asthenia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Chest pain
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Chills
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
15.4%
2/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Fatigue
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
28.6%
2/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
27.3%
3/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
23.1%
3/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Feeling cold
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Feeling hot
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Hot flush
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Irritability
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Psychiatric disorders
Somnolence
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Malaise
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Peripheral coldness
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
General disorders
Swelling
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Hepatobiliary disorders
Hepatitis
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Sedation
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
15.4%
2/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
33.3%
4/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
16.7%
2/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
15.4%
2/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
16.7%
2/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
18.2%
2/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Investigations
International normalised ratio increased
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
16.7%
2/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
15.4%
2/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
16.7%
2/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
18.2%
2/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
9.1%
1/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
14.3%
1/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
8.3%
1/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
|
Vascular disorders
Vasoconstriction
|
0.00%
0/10 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/2 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/7 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/11 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
7.7%
1/13 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
0.00%
0/12 • From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place