Trial Outcomes & Findings for An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection (NCT NCT03361956)
NCT ID: NCT03361956
Last Updated: 2022-11-17
Results Overview
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) \<60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
232 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2022-11-17
Participant Flow
As per planned analysis, the data for Part A Placebo + Nucleos(t)ide analog (NA) and Part B Placebo + NA arm was pooled into a single Placebo + NA arm for data interpretation since there was considerable time overlap in randomization between the two parts, with almost half of the participants of Part B recruited while Part A was still ongoing.
Participant milestones
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] less than (\<) 60 International units per milliliter \[IU/mL\]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg (Open Label)
Currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
Virologically suppressed or currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open-label)
Currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Virologically suppressed or currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
28
|
66
|
32
|
63
|
|
Overall Study
Currently Not Treated
|
22
|
28
|
33
|
32
|
33
|
|
Overall Study
Virologically Suppressed
|
21
|
0
|
33
|
0
|
30
|
|
Overall Study
COMPLETED
|
40
|
24
|
61
|
28
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
4
|
5
|
Reasons for withdrawal
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] less than (\<) 60 International units per milliliter \[IU/mL\]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg (Open Label)
Currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
Virologically suppressed or currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open-label)
Currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Virologically suppressed or currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
0
|
3
|
|
Overall Study
Disease Relapse
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] less than (\<) 60 International units per milliliter \[IU/mL\]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg (Open Label)
n=28 Participants
Currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=66 Participants
Virologically suppressed or currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open-label)
n=32 Participants
Currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=63 Participants
Virologically suppressed or currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 10.92 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 10.99 • n=21 Participants
|
40.1 years
STANDARD_DEVIATION 10.87 • n=10 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
162 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
230 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
110 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
105 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
BELGIUM
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Region of Enrollment
CANADA
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Region of Enrollment
CHINA
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
FRANCE
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Region of Enrollment
GERMANY
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Region of Enrollment
ITALY
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
JAPAN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Region of Enrollment
MALAYSIA
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Region of Enrollment
POLAND
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
SPAIN
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Region of Enrollment
TAIWAN
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Region of Enrollment
THAILAND
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
TURKEY
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Region of Enrollment
UKRAINE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED STATES
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-Treat Population (ITT) consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n'(number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=21 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24
HBeAg Positive
|
-0.251 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.3144
|
-0.096 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.3567
|
-0.142 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.3443
|
-0.203 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.4721
|
-0.411 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.4843
|
—
|
|
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24
HBeAg Negative
|
0.015 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.0880
|
0.053 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.2066
|
0.041 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.0939
|
0.064 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.0913
|
0.088 log10 IU per milliliter (log10 IU/mL)
Standard Deviation 0.1613
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) \<60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24
HBeAg Positive
|
0.008 log10 IU/mL
Standard Deviation 0.1224
|
-0.063 log10 IU/mL
Standard Deviation 0.2272
|
0.105 log10 IU/mL
Standard Deviation 0.1809
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24
HBeAg Negative
|
0.024 log10 IU/mL
Standard Deviation 0.0722
|
-0.017 log10 IU/mL
Standard Deviation 0.0677
|
0.092 log10 IU/mL
Standard Deviation 0.0556
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=28 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=66 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=32 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=63 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment- Emergent Adverse Events (AEs)
|
34 Participants
|
18 Participants
|
55 Participants
|
25 Participants
|
54 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 80Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=28 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=66 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=32 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=63 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 80Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
Number of participants with clinically significant changes in vital signs, physical examinations, ECG, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) were reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=28 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=66 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=32 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=63 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Clinical Laboratory Tests: Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Clinical Laboratory Tests: Blood biochemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Clinical Laboratory Tests: Blood coagulation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests
Clinical Laboratory Tests: Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=23 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Week 24: HBeAg Positive
|
-0.251 log10 IU/mL
Standard Deviation 0.3144
|
-0.096 log10 IU/mL
Standard Deviation 0.3567
|
-0.142 log10 IU/mL
Standard Deviation 0.3443
|
-0.203 log10 IU/mL
Standard Deviation 0.4721
|
-0.411 log10 IU/mL
Standard Deviation 0.4843
|
—
|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Week 24: HBeAg Negative
|
0.015 log10 IU/mL
Standard Deviation 0.0880
|
0.053 log10 IU/mL
Standard Deviation 0.2066
|
0.041 log10 IU/mL
Standard Deviation 0.0939
|
0.064 log10 IU/mL
Standard Deviation 0.0913
|
0.088 log10 IU/mL
Standard Deviation 0.1613
|
—
|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Week 48: HBeAg Positive
|
-0.109 log10 IU/mL
Standard Deviation 0.2065
|
—
|
0.061 log10 IU/mL
Standard Deviation 0.6817
|
-0.035 log10 IU/mL
Standard Deviation 0.6065
|
-0.811 log10 IU/mL
Standard Deviation 1.0053
|
—
|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Week 48: HBeAg Negative
|
0.027 log10 IU/mL
Standard Deviation 0.0969
|
—
|
-0.024 log10 IU/mL
Standard Deviation 0.1016
|
0.011 log10 IU/mL
Standard Deviation 0.1086
|
0.075 log10 IU/mL
Standard Deviation 0.1528
|
—
|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Follow-up Week 24: HBeAg Positive
|
-0.300 log10 IU/mL
Standard Deviation 0.3333
|
-0.786 log10 IU/mL
Standard Deviation 0.6879
|
-0.404 log10 IU/mL
Standard Deviation 0.5852
|
-0.230 log10 IU/mL
Standard Deviation 0.5110
|
-0.721 log10 IU/mL
Standard Deviation 0.5666
|
—
|
|
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time
Follow-up Week 24: HBeAg Negative
|
0.006 log10 IU/mL
Standard Deviation 0.1191
|
0.000 log10 IU/mL
Standard Deviation 0.1889
|
-0.068 log10 IU/mL
Standard Deviation 0.0999
|
-0.073 log10 IU/mL
Standard Deviation 0.1195
|
-0.017 log10 IU/mL
Standard Deviation 0.1533
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBsAg levels in virologically suppressed population based on HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Week 24: HBeAg Positive
|
0.008 log10 IU/mL
Standard Deviation 0.1224
|
-0.063 log10 IU/mL
Standard Deviation 0.2272
|
0.105 log10 IU/mL
Standard Deviation 0.1809
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Week 24: HBeAg Negative
|
0.024 log10 IU/mL
Standard Deviation 0.0722
|
-0.017 log10 IU/mL
Standard Deviation 0.0677
|
0.092 log10 IU/mL
Standard Deviation 0.0556
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Week 48: HBeAg Positive
|
0.043 log10 IU/mL
Standard Deviation 0.1374
|
-0.078 log10 IU/mL
Standard Deviation 0.2660
|
0.046 log10 IU/mL
Standard Deviation 0.2223
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Week 48: HBeAg Negative
|
0.011 log10 IU/mL
Standard Deviation 0.0736
|
-0.038 log10 IU/mL
Standard Deviation 0.0747
|
0.029 log10 IU/mL
Standard Deviation 0.0752
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Follow-up Week 24: HBeAg Positive
|
-0.088 log10 IU/mL
Standard Deviation 0.0492
|
-0.146 log10 IU/mL
Standard Deviation 0.2821
|
-0.159 log10 IU/mL
Standard Deviation 0.2141
|
—
|
—
|
—
|
|
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time
Follow-up Week 24: HBeAg Negative
|
-0.006 log10 IU/mL
Standard Deviation 0.0789
|
-0.119 log10 IU/mL
Standard Deviation 0.1172
|
-0.028 log10 IU/mL
Standard Deviation 0.0655
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg levels \<1,000 or \<100 IU/mL in currently not treated population based on their HBeAg status were reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=23 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 24: HBsAg<1000 IU/mL: HBeAg negative
|
15.4 Percentage of participants
|
23.1 Percentage of participants
|
4.8 Percentage of participants
|
0 Percentage of participants
|
10.5 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 24: HBsAg<100 IU/mL: HBeAg positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 24: HBsAg<1000 IU/mL: HBeAg positive
|
0 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 24: HBsAg<100 IU/mL: HBeAg negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 48: HBsAg<100 IU/mL: HBeAg positive
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 48: HBsAg<1000 IU/mL: HBeAg positive
|
0 Percentage of participants
|
—
|
50.0 Percentage of participants
|
0 Percentage of participants
|
20.0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 48: HBsAg<100 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Week 48: HBsAg<1000 IU/mL: HBeAg Negative
|
18.2 Percentage of participants
|
—
|
22.2 Percentage of participants
|
7.7 Percentage of participants
|
14.3 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive
|
0 Percentage of participants
|
10.0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population
Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative
|
18.2 Percentage of participants
|
23.1 Percentage of participants
|
18.8 Percentage of participants
|
7.1 Percentage of participants
|
5.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg levels \<1,000 or \<100 IU/mL in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 24: HBsAg<100 IU/mL: HBeAg positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 24: HBsAg<1000 IU/mL: HBeAg positive
|
20.0 Percentage of participants
|
11.1 Percentage of participants
|
10.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 24: HBsAg<100 IU/mL: HBeAg negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 24: HBsAg<1000 IU/mL: HBeAg negative
|
0 Percentage of participants
|
29.2 Percentage of participants
|
15.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 48: HBsAg<100 IU/mL: HBeAg positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 48: HBsAg<1000 IU/mL: HBeAg positive
|
20.0 Percentage of participants
|
12.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 48: HBsAg<100 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Week 48: HBsAg<1000 IU/mL: HBeAg Negative
|
7.7 Percentage of participants
|
33.3 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Follow-up Week 24: HBsAg<100 IU/mL: HBeAg positive
|
0 Percentage of participants
|
11.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg positive
|
25.0 Percentage of participants
|
11.1 Percentage of participants
|
44.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Follow-up Week 24: HBsAg<100 IU/mL: HBeAg negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population
Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg negative
|
13.3 Percentage of participants
|
34.8 Percentage of participants
|
7.1 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with \>0.5 log10 IU/mL or \>1 log10 IU/mL reduction in HBsAg from baseline in currently not treated population based on their HBeAg status were reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=23 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 24: >0.5 log10 IU/mL: HBeAg Positive
|
12.5 Percentage of participants
|
12.5 Percentage of participants
|
8.3 Percentage of participants
|
28.6 Percentage of participants
|
36.4 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 24: >1 log10IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
18.2 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 24: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 24: >1 log10 IU/mL: Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 48: >0.5 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
20.0 Percentage of participants
|
60.0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 48: >1 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
60.0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 48: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Week 48: >1 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive
|
14.3 Percentage of participants
|
60.0 Percentage of participants
|
33.3 Percentage of participants
|
30.0 Percentage of participants
|
54.5 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
40.0 Percentage of participants
|
16.7 Percentage of participants
|
7.7 Percentage of participants
|
27.3 Percentage of participants
|
—
|
|
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with \>0.5 log10 IU/mL or \>1 log10 IU/mL reduction in HBsAg from baseline in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
11.1 Percentage of participants
|
11.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 24: >0.5 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 24: >1 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 24: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 24: >1 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 48: >0.5 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 48: >1 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 48: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Week 48: >1 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who are randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants would be shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBV DNA levels in currently not treated population based on their HBeAg status was reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=22 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Week 24: HbeAg Positive
|
-5.211 log10 IU/mL
Standard Deviation 1.1986
|
-3.284 log10 IU/mL
Standard Deviation 2.1148
|
-5.531 log10 IU/mL
Standard Deviation 0.7915
|
-5.719 log10 IU/mL
Standard Deviation 0.8395
|
-5.883 log10 IU/mL
Standard Deviation 1.1396
|
—
|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Week 24:HbeAg Negative
|
-3.622 log10 IU/mL
Standard Deviation 1.3003
|
-3.469 log10 IU/mL
Standard Deviation 1.2901
|
-4.077 log10 IU/mL
Standard Deviation 0.9435
|
-3.545 log10 IU/mL
Standard Deviation 1.1482
|
-3.690 log10 IU/mL
Standard Deviation 1.5289
|
—
|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Week 48: HbeAg Positive
|
-6.359 log10 IU/mL
Standard Deviation 0.1989
|
—
|
-5.009 log10 IU/mL
Standard Deviation 1.8289
|
-6.413 log10 IU/mL
Standard Deviation 0.9121
|
-6.205 log10 IU/mL
Standard Deviation 1.3358
|
—
|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Week 48: HbeAg Negative
|
-3.650 log10 IU/mL
Standard Deviation 1.3342
|
—
|
-3.707 log10 IU/mL
Standard Deviation 1.6444
|
-3.313 log10 IU/mL
Standard Deviation 1.0138
|
-3.520 log10 IU/mL
Standard Deviation 1.2505
|
—
|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Follow-up Week 24: HbeAg Positive
|
-5.956 log10 IU/mL
Standard Deviation 0.6580
|
-6.318 log10 IU/mL
Standard Deviation 1.0238
|
-6.080 log10 IU/mL
Standard Deviation 0.8678
|
-6.262 log10 IU/mL
Standard Deviation 0.6278
|
-6.013 log10 IU/mL
Standard Deviation 1.8359
|
—
|
|
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population
Follow-up Week 24: HbeAg Negative
|
-3.727 log10 IU/mL
Standard Deviation 1.6598
|
-4.805 log10 IU/mL
Standard Deviation 1.0557
|
-4.165 log10 IU/mL
Standard Deviation 1.1102
|
-3.721 log10 IU/mL
Standard Deviation 1.1937
|
-3.906 log10 IU/mL
Standard Deviation 1.6486
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who are randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants would be shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBV DNA levels in virologically supressed population based on their HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Week 48: HbeAg Negative
|
0.000 log10 IU/mL
Standard Deviation 0.3896
|
-0.010 log10 IU/mL
Standard Deviation 0.3403
|
-0.093 log10 IU/mL
Standard Deviation 0.2645
|
—
|
—
|
—
|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Week 24: HbeAg Positive
|
-0.051 log10 IU/mL
Standard Deviation 0.1142
|
0.000 log10 IU/mL
Standard Deviation 0.3374
|
0.021 log10 IU/mL
Standard Deviation 0.2665
|
—
|
—
|
—
|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Week 24: HbeAg Negative
|
-0.032 log10 IU/mL
Standard Deviation 0.2184
|
0.016 log10 IU/mL
Standard Deviation 0.3626
|
-0.024 log10 IU/mL
Standard Deviation 0.2472
|
—
|
—
|
—
|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Week 48: HbeAg Positive
|
0.044 log10 IU/mL
Standard Deviation 0.2660
|
0.000 log10 IU/mL
Standard Deviation 0.3607
|
-0.233 log10 IU/mL
Standard Deviation 0.2817
|
—
|
—
|
—
|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Follow-up Week 24: HbeAg Positive
|
0.175 log10 IU/mL
Standard Deviation 0.3644
|
0.000 log10 IU/mL
Standard Deviation 0.3374
|
0.105 log10 IU/mL
Standard Deviation 0.5370
|
—
|
—
|
—
|
|
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population
Follow-up Week 24: HbeAg Negative
|
-0.032 log10 IU/mL
Standard Deviation 0.2832
|
-0.069 log10 IU/mL
Standard Deviation 0.3767
|
0.070 log10 IU/mL
Standard Deviation 0.3124
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with undetectable HBV DNA levels in currently not treated population based on their HBeAg status was evaluated.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=23 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Week 24: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Week 24: HBeAg Negative
|
23.1 Percentage of participants
|
14.3 Percentage of participants
|
14.3 Percentage of participants
|
18.8 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Week 48: HBeAg Positive
|
0 Percentage of participants
|
—
|
20.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Week 48: HBeAg Negative
|
27.3 Percentage of participants
|
—
|
55.6 Percentage of participants
|
15.4 Percentage of participants
|
28.6 Percentage of participants
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Follow-up Week 24: HBeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
15.4 Percentage of participants
|
11.9 Percentage of participants
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population
Follow-up Week 24: HBeAg Negative
|
36.4 Percentage of participants
|
38.5 Percentage of participants
|
18.8 Percentage of participants
|
35.7 Percentage of participants
|
23.5 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with undetectable HBV DNA levels in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Week 24: HBeAg positive
|
40.0 Percentage of participants
|
22.2 Percentage of participants
|
40.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Week 24: HBeAg negative
|
60.0 Percentage of participants
|
58.3 Percentage of participants
|
63.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Week 48: HBeAg positive
|
40.0 Percentage of participants
|
37.5 Percentage of participants
|
77.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Week 48: HBeAg negative
|
53.8 Percentage of participants
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Follow-up Week 24: HBeAg positive
|
25.0 Percentage of participants
|
44.4 Percentage of participants
|
44.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population
Follow-up Week 24: HBeAg negative
|
60.0 Percentage of participants
|
73.9 Percentage of participants
|
42.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBeAg levels in HBeAg positive currently not treated population was reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=8 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=10 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=12 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=14 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=11 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBeAg Levels in Currently Not Treated Population
Week 24
|
-0.811 log10 IU/mL
Standard Deviation 0.7953
|
-0.456 log10 IU/mL
Standard Deviation 0.2908
|
-0.487 log10 IU/mL
Standard Deviation 2974
|
-0.974 log10 IU/mL
Standard Deviation 0.8400
|
-0.701 log10 IU/mL
Standard Deviation 0.6645
|
—
|
|
Change From Baseline in HBeAg Levels in Currently Not Treated Population
Week 48
|
-2.250 log10 IU/mL
Standard Deviation 0.4010
|
—
|
-0.235 log10 IU/mL
Standard Deviation 0.0908
|
-1.779 log10 IU/mL
Standard Deviation 1.3525
|
-1.601 log10 IU/mL
Standard Deviation 1.2689
|
—
|
|
Change From Baseline in HBeAg Levels in Currently Not Treated Population
Follow-up Week 24
|
-1.139 log10 IU/mL
Standard Deviation 1.2528
|
-1.597 log10 IU/mL
Standard Deviation 1.1587
|
-0.876 log10 IU/mL
Standard Deviation 0.5178
|
-1.243 log10 IU/mL
Standard Deviation 0.9933
|
-1.215 log10 IU/mL
Standard Deviation 1.2910
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Change from baseline in HBeAg levels in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=5 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=9 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=10 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HBeAg Levels in Virologically Suppressed Population
Week 24
|
-0.313 log10 IU/mL
Standard Deviation 0.5281
|
-0.315 log10 IU/mL
Standard Deviation 0.4681
|
-0.162 log10 IU/mL
Standard Deviation 0.2037
|
—
|
—
|
—
|
|
Change From Baseline in HBeAg Levels in Virologically Suppressed Population
Week 48
|
-0.589 log10 IU/mL
Standard Deviation 0.6616
|
-0.393 log10 IU/mL
Standard Deviation 0.4866
|
-0.291 log10 IU/mL
Standard Deviation 0.2376
|
—
|
—
|
—
|
|
Change From Baseline in HBeAg Levels in Virologically Suppressed Population
Follow-up Week 24
|
-0.772 log10 IU/mL
Standard Deviation 0.7059
|
-0.387 log10 IU/mL
Standard Deviation 0.5218
|
-0.351 log10 IU/mL
Standard Deviation 0.2877
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with \>0.5 log10 IU/mL and \>1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive currently not treated population was reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=8 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=10 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=12 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=14 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=11 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Week 24: >0.5 log10 IU/mL
|
62.5 Percentage of participants
|
50 Percentage of participants
|
41.7 Percentage of participants
|
78.6 Percentage of participants
|
63.6 Percentage of participants
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Week 24: >1 log10 IU/mL
|
37.5 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
42.9 Percentage of participants
|
36.4 Percentage of participants
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Week 48: >0.5 log10 IU/mL
|
100 Percentage of participants
|
—
|
0 Percentage of participants
|
100.0 Percentage of participants
|
80.0 Percentage of participants
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Week 48: >1 log10 IU/mL
|
100.0 Percentage of participants
|
—
|
0 Percentage of participants
|
80.0 Percentage of participants
|
80.0 Percentage of participants
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >0.5 log10 IU/mL
|
42.9 Percentage of participants
|
80.0 Percentage of participants
|
91.7 Percentage of participants
|
84.6 Percentage of participants
|
72.7 Percentage of participants
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population
Follow-up Week 24: >1 log10 IU/mL
|
28.6 Percentage of participants
|
70.0 Percentage of participants
|
25.0 Percentage of participants
|
61.5 Percentage of participants
|
45.5 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with \>0.5 log10 IU/mL and \>1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=5 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=9 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=10 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Week 24: >0.5 log10 IU/mL
|
20 Percentage of participants
|
33.3 Percentage of participants
|
10 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Week 24: >1 log10 IU/mL
|
20 Percentage of participants
|
11.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Week 48: >0.5 log10 IU/mL
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
22.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Week 48: >1 log10 IU/mL
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >0.5 log10 IU/mL
|
50.0 Percentage of participants
|
22.2 Percentage of participants
|
22.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population
Follow-up Week 24: >1 log10 IU/mL
|
25.0 Percentage of participants
|
11.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg seroclearance in currently not treated population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoints only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=20 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=29 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=28 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Week 24: HbeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Week 24: HbeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Week 48: HbeAg Positive
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population
Week 48: HbeAg Negative
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg seroclearance in virologically suppressed population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed for specified arms and specific timepoints only .
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=20 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Week 24: HbeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Week 24: HbeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Week 48: HbeAg Positive
|
20.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population
Week 48: HbeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg seroconversion in currently not treated population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified timepoints only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=20 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=32 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=28 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=28 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Week 24: HbeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Week 24: HbeAg negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Week 48: HbeAg Positive
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population
Week 48: HbeAg negative
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with HBsAg seroconversion in virologically suppressed population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified arms and specified timepoints only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=29 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Week 24: HbeAg negative
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Week 48: HbeAg Positive
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Week 48: HbeAg negative
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population
Week 24: HbeAg Positive
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: The safety population included all participants who received at least one dose of the study agent with ALT values higher than upper limit of normal (ULN) at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with normalized ALT levels in currently not treated population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=17 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=19 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=27 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=25 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=24 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Week 24: HBeAg positive
|
62.5 Percentage of participants
|
60.0 Percentage of participants
|
54.5 Percentage of participants
|
64.3 Percentage of participants
|
44.4 Percentage of participants
|
—
|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Week 24: HBeAg negative
|
55.6 Percentage of participants
|
91.7 Percentage of participants
|
68.8 Percentage of participants
|
72.7 Percentage of participants
|
80.0 Percentage of participants
|
—
|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Week 48: HBeAg positive
|
100.0 Percentage of participants
|
—
|
100.0 Percentage of participants
|
60.0 Percentage of participants
|
40.0 Percentage of participants
|
—
|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Week 48: HBeAg negative
|
75.0 Percentage of participants
|
—
|
100.0 Percentage of participants
|
77.8 Percentage of participants
|
63.6 Percentage of participants
|
—
|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Follow-up Week 24: HBeAg positive
|
71.4 Percentage of participants
|
71.4 Percentage of participants
|
63.6 Percentage of participants
|
61.5 Percentage of participants
|
77.8 Percentage of participants
|
—
|
|
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population
Follow-up Week 24: HBeAg negative
|
87.5 Percentage of participants
|
100.0 Percentage of participants
|
83.3 Percentage of participants
|
90.9 Percentage of participants
|
86.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48 and Follow-up Week 24Population: The safety population included all participants who received at least one dose of the study agent with ALT values higher than ULN at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with normalized ALT levels in virologically suppressed population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=2 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=4 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=5 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Week 24: HBeAg Positive
|
—
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Week 24: HBeAg Negative
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Week 48: HBeAg positive
|
—
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Week 48: HBeAg negative
|
50.0 Percentage of participants
|
0 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Follow-up Week 24: HBeAg Positive
|
—
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population
Follow-up Week 24: HBeAg negative
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with virological breakthrough in currently not treated population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by \>1 log10 from nadir level or confirmed on treatment level \>200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=22 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=28 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=32 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=33 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Week 24: HbeAg Positive
|
0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Week 24: HbeAg Negative
|
0 Percentage of participants
|
18.8 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Week 48: HbeAg Positive
|
100.0 Percentage of participants
|
—
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population
Week 48: HbeAg Negative
|
0 Percentage of participants
|
33.3 Percentage of participants
|
10.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Percentage of participants with virological breakthrough in virologically suppressed population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by \>1 log10 from nadir level or confirmed on treatment level \>200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=21 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=33 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=30 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Week 24: HbeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Week 24: HbeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Week 48: HbeAg Positive
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population
Week 48: HbeAg Negative
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The pharmacokinetic (PK) analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in currently not treated population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=1 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=3 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=6 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=7 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 4: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.417 nanograms per milliliter (ng/mL)
Standard Deviation 0.143
|
0.414 nanograms per milliliter (ng/mL)
Standard Deviation 0.0742
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 8: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.353 nanograms per milliliter (ng/mL)
Standard Deviation 0.226
|
0.466 nanograms per milliliter (ng/mL)
Standard Deviation 0.0913
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 12: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.467 nanograms per milliliter (ng/mL)
Standard Deviation 0.188
|
0.479 nanograms per milliliter (ng/mL)
Standard Deviation 0.0650
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Day 1: 0 hours
|
—
|
—
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Day 1: 2 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
1.39 nanograms per milliliter (ng/mL)
Standard Deviation 0.709
|
1.18 nanograms per milliliter (ng/mL)
Standard Deviation 0.197
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 1: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.321 nanograms per milliliter (ng/mL)
Standard Deviation 0.0961
|
0.289 nanograms per milliliter (ng/mL)
Standard Deviation 0.0351
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 2: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.285 nanograms per milliliter (ng/mL)
Standard Deviation 0.166
|
0.377 nanograms per milliliter (ng/mL)
Standard Deviation 0.0531
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 20: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.441 nanograms per milliliter (ng/mL)
Standard Deviation 0.147
|
0.481 nanograms per milliliter (ng/mL)
Standard Deviation 0.0625
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 24: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.395 nanograms per milliliter (ng/mL)
Standard Deviation 0.309
|
0.385 nanograms per milliliter (ng/mL)
Standard Deviation 0.0415
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 28: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.527 nanograms per milliliter (ng/mL)
Standard Deviation 0.0302
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 32: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
—
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.462 nanograms per milliliter (ng/mL)
Standard Deviation 0.0410
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 36: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
—
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.442 nanograms per milliliter (ng/mL)
Standard Deviation 0.0517
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 44: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
—
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.438 nanograms per milliliter (ng/mL)
Standard Deviation 0.0352
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Week 48: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
—
|
0.434 nanograms per milliliter (ng/mL)
Standard Deviation 0.0968
|
0.539 nanograms per milliliter (ng/mL)
Standard Deviation 0.0414
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Follow-up: Week 2
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.542 nanograms per milliliter (ng/mL)
Standard Deviation 0.311
|
0.307 nanograms per milliliter (ng/mL)
Standard Deviation 0.176
|
—
|
—
|
|
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population
Follow-up: Week 4
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.354 nanograms per milliliter (ng/mL)
Standard Deviation 0.260
|
0.309 nanograms per milliliter (ng/mL)
Standard Deviation 0.161
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in virologically suppressed population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=4 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=2 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=14 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=6 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Day 1: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
—
|
0.683 ng/mL
Standard Deviation 0.414
|
—
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Day 1: 2 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
1.86 ng/mL
Standard Deviation 0.639
|
1.89 ng/mL
Standard Deviation 0.429
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 1: 0 hours
|
1.94 ng/mL
Standard Deviation 2.43
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.464 ng/mL
Standard Deviation 0.143
|
0.472 ng/mL
Standard Deviation 0.120
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 2: 0 hours
|
0.871 ng/mL
Standard Deviation 0.909
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.469 ng/mL
Standard Deviation 0.153
|
0.469 ng/mL
Standard Deviation 0.0835
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 4: 0 hours
|
0.647 ng/mL
Standard Deviation 0.628
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.529 ng/mL
Standard Deviation 0.198
|
0.539 ng/mL
Standard Deviation 0.108
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 8: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.496 ng/mL
Standard Deviation 0.179
|
0.493 ng/mL
Standard Deviation 0.0816
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 12: 0 hours
|
0.277 ng/mL
Standard Deviation 0.0733
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.454 ng/mL
Standard Deviation 0.135
|
0.548 ng/mL
Standard Deviation 0.0535
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 24: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.491 ng/mL
Standard Deviation 0.144
|
0.576 ng/mL
Standard Deviation 0.121
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 28: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
0.446 ng/mL
Standard Deviation 0.148
|
0.519 ng/mL
Standard Deviation 0.153
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 20: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
0.617 ng/mL
Standard Deviation 0.408
|
0.537 ng/mL
Standard Deviation 0.109
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 32: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
0.467 ng/mL
Standard Deviation 0.201
|
0.489 ng/mL
Standard Deviation 0.144
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 36: 0 hours
|
0.962 ng/mL
Standard Deviation 1.07
|
—
|
0.487 ng/mL
Standard Deviation 0.185
|
0.526 ng/mL
Standard Deviation 0.109
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 44: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
0.525 ng/mL
Standard Deviation 0.177
|
0.517 ng/mL
Standard Deviation 0.121
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Week 48: 0 hours
|
0.766 ng/mL
Standard Deviation 0.594
|
—
|
0.554 ng/mL
Standard Deviation 0.287
|
0.537 ng/mL
Standard Deviation 0.105
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Follow-up: Week 2
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.635 ng/mL
Standard Deviation 0.449
|
0.433 ng/mL
Standard Deviation 0.117
|
—
|
—
|
|
Plasma Concentrations of ETV in Virologically Suppressed Population
Follow-up: Week 4
|
1.00 ng/mL
Standard Deviation 1.13
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
0.445 ng/mL
Standard Deviation 0.164
|
0.725 ng/mL
Standard Deviation 0.598
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=9 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=8 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=24 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=25 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Follow-up: Week 4
|
72.4 nanograms per milliliter (ng/mL)
Standard Deviation 32.1
|
57.1 nanograms per milliliter (ng/mL)
Standard Deviation 13.6
|
68.7 nanograms per milliliter (ng/mL)
Standard Deviation 54.3
|
68.4 nanograms per milliliter (ng/mL)
Standard Deviation 43.6
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Day 1: 0 hours
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not estimable due to small sample size.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Day 1: 2 hours
|
277 nanograms per milliliter (ng/mL)
Standard Deviation 116
|
170 nanograms per milliliter (ng/mL)
Standard Deviation 114
|
372 nanograms per milliliter (ng/mL)
Standard Deviation 478
|
249 nanograms per milliliter (ng/mL)
Standard Deviation 96.9
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 1: 0 hours
|
79.6 nanograms per milliliter (ng/mL)
Standard Deviation 38.1
|
92.7 nanograms per milliliter (ng/mL)
Standard Deviation 134
|
92.6 nanograms per milliliter (ng/mL)
Standard Deviation 37.4
|
97.8 nanograms per milliliter (ng/mL)
Standard Deviation 27.7
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 2: 0 hours
|
64.2 nanograms per milliliter (ng/mL)
Standard Deviation 34.5
|
50.1 nanograms per milliliter (ng/mL)
Standard Deviation 14.1
|
81.5 nanograms per milliliter (ng/mL)
Standard Deviation 22.6
|
97.6 nanograms per milliliter (ng/mL)
Standard Deviation 23.7
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 4: 0 hours
|
62.9 nanograms per milliliter (ng/mL)
Standard Deviation 17.7
|
46.5 nanograms per milliliter (ng/mL)
Standard Deviation 10.5
|
90.2 nanograms per milliliter (ng/mL)
Standard Deviation 25.8
|
99.6 nanograms per milliliter (ng/mL)
Standard Deviation 26.4
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 8: 0 hours
|
66.3 nanograms per milliliter (ng/mL)
Standard Deviation 23.7
|
54.2 nanograms per milliliter (ng/mL)
Standard Deviation 18.3
|
92.6 nanograms per milliliter (ng/mL)
Standard Deviation 25.7
|
108 nanograms per milliliter (ng/mL)
Standard Deviation 36.0
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 12: 0 hours
|
67.5 nanograms per milliliter (ng/mL)
Standard Deviation 31.2
|
51.3 nanograms per milliliter (ng/mL)
Standard Deviation 15.9
|
92.6 nanograms per milliliter (ng/mL)
Standard Deviation 29.1
|
102 nanograms per milliliter (ng/mL)
Standard Deviation 35.3
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 20: 0 hours
|
72.6 nanograms per milliliter (ng/mL)
Standard Deviation 34.2
|
51.2 nanograms per milliliter (ng/mL)
Standard Deviation 13.8
|
85.8 nanograms per milliliter (ng/mL)
Standard Deviation 30.6
|
115 nanograms per milliliter (ng/mL)
Standard Deviation 41.7
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 24: 0 hours
|
75.9 nanograms per milliliter (ng/mL)
Standard Deviation 51.0
|
50.5 nanograms per milliliter (ng/mL)
Standard Deviation 20.1
|
89.1 nanograms per milliliter (ng/mL)
Standard Deviation 30.1
|
99.3 nanograms per milliliter (ng/mL)
Standard Deviation 37.8
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 28: 0 hours
|
74.4 nanograms per milliliter (ng/mL)
Standard Deviation 38.1
|
51.2 nanograms per milliliter (ng/mL)
Standard Deviation 19.9
|
99.0 nanograms per milliliter (ng/mL)
Standard Deviation 32.6
|
108 nanograms per milliliter (ng/mL)
Standard Deviation 39.0
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 32: 0 hours
|
78.8 nanograms per milliliter (ng/mL)
Standard Deviation 59.6
|
52.7 nanograms per milliliter (ng/mL)
Standard Deviation 26.1
|
89.6 nanograms per milliliter (ng/mL)
Standard Deviation 37.1
|
88.5 nanograms per milliliter (ng/mL)
Standard Deviation 25.6
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 36: 0 hours
|
78.9 nanograms per milliliter (ng/mL)
Standard Deviation 55.8
|
42.5 nanograms per milliliter (ng/mL)
Standard Deviation 19.3
|
96.0 nanograms per milliliter (ng/mL)
Standard Deviation 38.3
|
101 nanograms per milliliter (ng/mL)
Standard Deviation 34.2
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 44: 0 hours
|
86.3 nanograms per milliliter (ng/mL)
Standard Deviation 30.8
|
46.3 nanograms per milliliter (ng/mL)
Standard Deviation 26.0
|
81.8 nanograms per milliliter (ng/mL)
Standard Deviation 38.9
|
105 nanograms per milliliter (ng/mL)
Standard Deviation 33.5
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Week 48: 0 hours
|
76.4 nanograms per milliliter (ng/mL)
Standard Deviation 40
|
47.8 nanograms per milliliter (ng/mL)
Standard Deviation 18.6
|
89.5 nanograms per milliliter (ng/mL)
Standard Deviation 49.8
|
100 nanograms per milliliter (ng/mL)
Standard Deviation 29.9
|
—
|
—
|
|
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population
Follow-up: Week 2
|
73.8 nanograms per milliliter (ng/mL)
Standard Deviation 37.1
|
52.1 nanograms per milliliter (ng/mL)
Standard Deviation 17.3
|
65.7 nanograms per milliliter (ng/mL)
Standard Deviation 29.5
|
73.5 nanograms per milliliter (ng/mL)
Standard Deviation 23.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=5 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=8 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=18 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=19 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Day 1: 0 hours
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
68.9 ng/mL
Standard Deviation 10.1
|
63.3 ng/mL
Standard Deviation 27.4
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Day 1: 2 hours
|
274 ng/mL
Standard Deviation 153
|
311 ng/mL
Standard Deviation 92.5
|
306 ng/mL
Standard Deviation 145
|
364 ng/mL
Standard Deviation 260
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 1: 0 hours
|
76.8 ng/mL
Standard Deviation 40.8
|
59.2 ng/mL
Standard Deviation 15.7
|
97.9 ng/mL
Standard Deviation 38.0
|
97.1 ng/mL
Standard Deviation 36.8
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 2: 0 hours
|
82.0 ng/mL
Standard Deviation 53.0
|
65.9 ng/mL
Standard Deviation 18.9
|
97.5 ng/mL
Standard Deviation 34.0
|
114 ng/mL
Standard Deviation 51.0
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 4: 0 hours
|
83.1 ng/mL
Standard Deviation 54.8
|
66.9 ng/mL
Standard Deviation 20.3
|
96.9 ng/mL
Standard Deviation 25.0
|
110 ng/mL
Standard Deviation 41.4
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 8: 0 hours
|
84.0 ng/mL
Standard Deviation 54.1
|
65.5 ng/mL
Standard Deviation 28.9
|
118 ng/mL
Standard Deviation 48.0
|
109 ng/mL
Standard Deviation 32.2
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 12: 0 hours
|
98.8 ng/mL
Standard Deviation 73.6
|
63.5 ng/mL
Standard Deviation 21.6
|
99.4 ng/mL
Standard Deviation 33.8
|
130 ng/mL
Standard Deviation 87.8
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 20: 0 hours
|
99.6 ng/mL
Standard Deviation 85.0
|
64.8 ng/mL
Standard Deviation 23.3
|
120 ng/mL
Standard Deviation 30.1
|
127 ng/mL
Standard Deviation 64.9
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 24: 0 hours
|
78.3 ng/mL
Standard Deviation 33.4
|
73.8 ng/mL
Standard Deviation 33.0
|
104 ng/mL
Standard Deviation 29.9
|
113 ng/mL
Standard Deviation 47.6
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 28: 0 hours
|
81.7 ng/mL
Standard Deviation 37.7
|
70.6 ng/mL
Standard Deviation 28.1
|
110 ng/mL
Standard Deviation 43.2
|
155 ng/mL
Standard Deviation 107
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 32: 0 hours
|
75.5 ng/mL
Standard Deviation 54.8
|
61.2 ng/mL
Standard Deviation 21.2
|
43.2 ng/mL
Standard Deviation 36.4
|
139 ng/mL
Standard Deviation 93.3
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 36: 0 hours
|
80.2 ng/mL
Standard Deviation 50.3
|
80.2 ng/mL
Standard Deviation 31.2
|
101 ng/mL
Standard Deviation 33.1
|
132 ng/mL
Standard Deviation 90.2
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 44: 0 hours
|
72.7 ng/mL
Standard Deviation 54.9
|
93.0 ng/mL
Standard Deviation 64.2
|
109 ng/mL
Standard Deviation 53.4
|
129 ng/mL
Standard Deviation 73.6
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Week 48: 0 hours
|
87.6 ng/mL
Standard Deviation 58.5
|
66.2 ng/mL
Standard Deviation 22.1
|
114 ng/mL
Standard Deviation 31.7
|
133 ng/mL
Standard Deviation 117
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Follow-up: Week 2
|
86.5 ng/mL
Standard Deviation 73.8
|
51.9 ng/mL
Standard Deviation 23.4
|
73.2 ng/mL
Standard Deviation 18.5
|
136 ng/mL
Standard Deviation 95.5
|
—
|
—
|
|
Plasma Concentrations of TDF in Virologically Suppressed Population
Follow-up: Week 4
|
74.7 ng/mL
Standard Deviation 47.6
|
59.7 ng/mL
Standard Deviation 23.4
|
71.2 ng/mL
Standard Deviation 33.0
|
95.8 ng/mL
Standard Deviation 83.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of JNJ-56136379 in currently not treated population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=27 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=32 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=8 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=24 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=7 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
n=25 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 44: 0 hours
|
—
|
11198 ng/mL
Standard Deviation 2749
|
4507 ng/mL
Standard Deviation 1121
|
3430 ng/mL
Standard Deviation 1346
|
11570 ng/mL
Standard Deviation 2674
|
11016 ng/mL
Standard Deviation 4277
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 48: 0 hours
|
—
|
11797 ng/mL
Standard Deviation 2482
|
—
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
11220 ng/mL
Standard Deviation 2464
|
10740 ng/mL
Standard Deviation 2400
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Day 1: 0 hour
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due below qualification limit BQL limit \<10.0 ng/mL.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due below qualification limit BQL limit \<10.0 ng/mL.
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Day 1: 2 hour
|
709 ng/mL
Standard Deviation 307
|
2143 ng/mL
Standard Deviation 1300
|
520 ng/mL
Standard Deviation 279
|
806 ng/mL
Standard Deviation 306
|
2287 ng/mL
Standard Deviation 946
|
2021 ng/mL
Standard Deviation 893
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 1: 0 hours
|
2269 ng/mL
Standard Deviation 597
|
7339 ng/mL
Standard Deviation 2040
|
2264 ng/mL
Standard Deviation 455
|
2368 ng/mL
Standard Deviation 695
|
6461 ng/mL
Standard Deviation 2014
|
7138 ng/mL
Standard Deviation 2280
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 2: 0 hours
|
3424 ng/mL
Standard Deviation 845
|
10894 ng/mL
Standard Deviation 2631
|
3094 ng/mL
Standard Deviation 892
|
3702 ng/mL
Standard Deviation 1028
|
9381 ng/mL
Standard Deviation 2168
|
10588 ng/mL
Standard Deviation 3568
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 4: 0 hours
|
4116 ng/mL
Standard Deviation 941
|
12827 ng/mL
Standard Deviation 3104
|
4368 ng/mL
Standard Deviation 1216
|
4697 ng/mL
Standard Deviation 1474
|
10760 ng/mL
Standard Deviation 2162
|
12513 ng/mL
Standard Deviation 4229
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 8: 0 hours
|
4617 ng/mL
Standard Deviation 1195
|
13697 ng/mL
Standard Deviation 3702
|
5006 ng/mL
Standard Deviation 1528
|
4719 ng/mL
Standard Deviation 1465
|
11027 ng/mL
Standard Deviation 2009
|
13037 ng/mL
Standard Deviation 4394
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 12: 0 hours
|
4130 ng/mL
Standard Deviation 1145
|
12676 ng/mL
Standard Deviation 3431
|
4976 ng/mL
Standard Deviation 1302
|
4582 ng/mL
Standard Deviation 1324
|
11347 ng/mL
Standard Deviation 1754
|
12524 ng/mL
Standard Deviation 4756
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 20: 0 hours
|
3754 ng/mL
Standard Deviation 1132
|
12757 ng/mL
Standard Deviation 4298
|
4648 ng/mL
Standard Deviation 1528
|
4698 ng/mL
Standard Deviation 1661
|
10517 ng/mL
Standard Deviation 2031
|
11425 ng/mL
Standard Deviation 3719
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 24: 0 hours
|
3613 ng/mL
Standard Deviation 813
|
12626 ng/mL
Standard Deviation 3396
|
4650 ng/mL
Standard Deviation 1461
|
4767 ng/mL
Standard Deviation 1601
|
10888 ng/mL
Standard Deviation 1576
|
11625 ng/mL
Standard Deviation 5087
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 28: 0 hours
|
4733 ng/mL
Standard Deviation 350
|
12025 ng/mL
Standard Deviation 3229
|
4300 ng/mL
Standard Deviation 1355
|
4439 ng/mL
Standard Deviation 1446
|
11753 ng/mL
Standard Deviation 2719
|
11746 ng/mL
Standard Deviation 4752
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 32: 0 hours
|
—
|
12162 ng/mL
Standard Deviation 2780
|
4677 ng/mL
Standard Deviation 646
|
4825 ng/mL
Standard Deviation 2429
|
9840 ng/mL
Standard Deviation 3770
|
12119 ng/mL
Standard Deviation 4062
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Week 36: 0 hours
|
—
|
11289 ng/mL
Standard Deviation 2973
|
4463 ng/mL
Standard Deviation 1444
|
4144 ng/mL
Standard Deviation 1599
|
11350 ng/mL
Standard Deviation 3439
|
11192 ng/mL
Standard Deviation 5191
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Follow-up: Week 2
|
916 ng/mL
Standard Deviation 930
|
2459 ng/mL
Standard Deviation 1529
|
1330 ng/mL
Standard Deviation 887
|
909 ng/mL
Standard Deviation 740
|
1922 ng/mL
Standard Deviation 1628
|
2192 ng/mL
Standard Deviation 1535
|
|
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population
Follow-up: Week 4
|
242 ng/mL
Standard Deviation 359
|
494 ng/mL
Standard Deviation 427
|
320 ng/mL
Standard Deviation 276
|
226 ng/mL
Standard Deviation 236
|
572 ng/mL
Standard Deviation 624
|
1025 ng/mL
Standard Deviation 1523
|
SECONDARY outcome
Timeframe: Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
Plasma concentrations of JNJ-56136379 in virologically suppressed population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=15 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=17 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=8 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=19 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 1: 0 hours
|
2144 ng/mL
Standard Deviation 553
|
2301 ng/mL
Standard Deviation 639
|
5758 ng/mL
Standard Deviation 1081
|
7280 ng/mL
Standard Deviation 2098
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 2: 0 hours
|
3193 ng/mL
Standard Deviation 1017
|
3206 ng/mL
Standard Deviation 710
|
8485 ng/mL
Standard Deviation 2269
|
10077 ng/mL
Standard Deviation 2886
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 4: 0 hours
|
3689 ng/mL
Standard Deviation 1178
|
3694 ng/mL
Standard Deviation 815
|
10106 ng/mL
Standard Deviation 2838
|
12167 ng/mL
Standard Deviation 4271
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 8: 0 hours
|
3917 ng/mL
Standard Deviation 1131
|
3998 ng/mL
Standard Deviation 1376
|
11295 ng/mL
Standard Deviation 3829
|
13352 ng/mL
Standard Deviation 6072
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 12: 0 hours
|
4194 ng/mL
Standard Deviation 1279
|
3813 ng/mL
Standard Deviation 945
|
10404 ng/mL
Standard Deviation 4246
|
12776 ng/mL
Standard Deviation 5191
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 20: 0 hours
|
3948 ng/mL
Standard Deviation 1151
|
4134 ng/mL
Standard Deviation 1375
|
10761 ng/mL
Standard Deviation 3980
|
12432 ng/mL
Standard Deviation 4249
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 24: 0 hours
|
3989 ng/mL
Standard Deviation 957
|
3836 ng/mL
Standard Deviation 1160
|
10219 ng/mL
Standard Deviation 3370
|
11542 ng/mL
Standard Deviation 4612
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 28: 0 hours
|
4259 ng/mL
Standard Deviation 1083
|
3506 ng/mL
Standard Deviation 1032
|
9959 ng/mL
Standard Deviation 2929
|
11344 ng/mL
Standard Deviation 4482
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 32: 0 hours
|
3788 ng/mL
Standard Deviation 841
|
3721 ng/mL
Standard Deviation 1088
|
10189 ng/mL
Standard Deviation 3160
|
12099 ng/mL
Standard Deviation 6301
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 36: 0 hours
|
3801 ng/mL
Standard Deviation 1170
|
3535 ng/mL
Standard Deviation 964
|
10036 ng/mL
Standard Deviation 2786
|
12227 ng/mL
Standard Deviation 5396
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 44: 0 hours
|
3998 ng/mL
Standard Deviation 1139
|
3784 ng/mL
Standard Deviation 1056
|
9634 ng/mL
Standard Deviation 3707
|
14853 ng/mL
Standard Deviation 7977
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Week 48: 0 hours
|
3918 ng/mL
Standard Deviation 1259
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
15080 ng/mL
Standard Deviation 8060
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Day 1: 0 hour
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
|
—
|
NA ng/mL
Standard Deviation NA
Here "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Day 1: 2 hour
|
857 ng/mL
Standard Deviation 238
|
616 ng/mL
Standard Deviation 385
|
2103 ng/mL
Standard Deviation 1400
|
2083 ng/mL
Standard Deviation 1022
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Follow-up: Week 2
|
621 ng/mL
Standard Deviation 607
|
912 ng/mL
Standard Deviation 585
|
1919 ng/mL
Standard Deviation 1359
|
3190 ng/mL
Standard Deviation 4462
|
—
|
—
|
|
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population
Follow-up: Week 4
|
89.8 ng/mL
Standard Deviation 102
|
204 ng/mL
Standard Deviation 209
|
389 ng/mL
Standard Deviation 384
|
1066 ng/mL
Standard Deviation 2319
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
Number of participants with treatment-associated mutations were reported. Viral genome sequence analysis was performed to evaluate emergence of mutations associated with JNJ-56136379 considering 15 HBV core protein positions of interest. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=23 Participants
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part A: JNJ-56136379 75 mg + NA
n=22 Participants
Virologically suppressed received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
n=17 Participants
Virologically suppressed participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg (Open Label)
n=14 Participants
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Part B: JNJ-56136379 250 mg + NA (TDF)
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Associated Mutations
Emergence of mutations during 24 weeks (Week 0 to Week 24)
|
8 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Associated Mutations
Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Associated Mutations
Emergence of mutations on NA treatment (Up to Follow-up Week 24)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment Extension Phase: Parts A and B: Pooled Placebo + NA
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 participants at risk
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label)
n=28 participants at risk
Currently not treated participants received 3\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA
n=66 participants at risk
Virologically suppressed or currently not treated participants received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label)
n=32 participants at risk
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA
n=63 participants at risk
Virologically suppressed or currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Parts A and B: Pooled Placebo + NA
n=33 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label)
n=3 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75mg from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA
n=43 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label)
n=20 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA
n=48 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Colitis
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Toxic Shock Syndrome Streptococcal
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Neck Syndrome
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Necrosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Ovarian Haemorrhage
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
Other adverse events
| Measure |
Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)
n=43 participants at risk
Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label)
n=28 participants at risk
Currently not treated participants received 3\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA
n=66 participants at risk
Virologically suppressed or currently not treated participants received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label)
n=32 participants at risk
Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA
n=63 participants at risk
Virologically suppressed or currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Parts A and B: Pooled Placebo + NA
n=33 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label)
n=3 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75mg from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA
n=43 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label)
n=20 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA
n=48 participants at risk
Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Hepatitis B Dna Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Defect Conduction Intraventricular
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Lipase Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Endocrine disorders
Goitre
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Eye disorders
Cataract
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Eye disorders
Dry Eye
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Eye disorders
Swelling of Eyelid
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
8.3%
4/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.0%
2/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
8.3%
4/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
2/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.0%
3/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
2/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Poor Quality Sleep
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.1%
3/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Tongue Disorder
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
11.6%
5/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Asthenia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Chest Discomfort
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Chest Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Cyst
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Fatigue
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
4/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
12.1%
4/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.3%
4/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
8.3%
4/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
2/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Malaise
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Pyrexia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
General disorders
Thirst
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Hepatic Cyst
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Hepatobiliary disorders
Ocular Icterus
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Alveolar Osteitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Asymptomatic Bacteriuria
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Bronchitis Viral
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Cystitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Furuncle
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.0%
2/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Influenza
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Laryngitis Viral
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.5%
3/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.4%
3/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
21.2%
7/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
11.6%
5/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
16.7%
8/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
33.3%
1/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.0%
2/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Suspected Covid-19
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.5%
3/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
18.6%
8/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
20.0%
4/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
8.3%
4/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Viral Pharyngitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Viral Tracheitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
33.3%
1/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Gingival Injury
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.3%
4/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
15.0%
3/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
8.3%
4/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Amylase Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
33.3%
1/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Calcium Decreased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.1%
3/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.0%
3/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Magnesium Decreased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Triglycerides
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Electrocardiogram T Wave Inversion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
15.0%
3/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Protein Urine Present
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Ultrasound Liver Abnormal
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Urinary Sediment Present
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Urine Leukocyte Esterase Positive
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Investigations
Weight Decreased
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Abnormal Loss of Weight
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Impaired Fasting Glucose
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.4%
5/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
33.3%
1/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
11.6%
5/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.0%
2/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Joint Noise
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.0%
2/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/23 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
15.0%
3/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.7%
3/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.6%
5/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.4%
3/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
12.1%
4/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
14.0%
6/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
20.0%
4/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
25.0%
12/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Neuromuscular Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Parkinson's Disease
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
2/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Aggression
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.1%
2/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Attention Deficit Hyperactivity Disorder
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.2%
2/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Renal and urinary disorders
Urinary Tract Discomfort
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
2/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Alopecia Areata
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
33.3%
1/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.7%
2/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
2/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Lichen Planus
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.1%
2/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
10.4%
5/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.5%
1/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
9.4%
3/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
7.0%
3/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
4.2%
2/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.6%
1/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
1.6%
1/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.1%
1/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Surgical and medical procedures
Abortion Induced
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Surgical and medical procedures
Dental Implantation
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
2.3%
1/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Vascular disorders
Haematoma
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
5.0%
1/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.1%
1/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
6.2%
3/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/28 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/66 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/32 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/63 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
3.0%
1/33 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/3 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/43 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/20 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
0.00%
0/48 • From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER