Trial Outcomes & Findings for Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC (NCT NCT04594694)
NCT ID: NCT04594694
Last Updated: 2026-07-16
Results Overview
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP over time will be analyzed using a mixed model for repeated measures (MMRM) to assess treatment group effects across study visits. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from Baseline was calculated as post Baseline value minus Baseline value.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2026-07-16
Participant Flow
This was a Phase 2, Proof -of-concept, randomized, double-blind (DB), parallel-group study that evaluated the efficacy, safety, and tolerability of obeticholic acid (OCA) administered in combination with 2 different Bezafibrate (BZF) doses or BZF alone participants with primary biliary cholangitis (PBC) for up to 12 weeks.
A total of 75 participants were enrolled. Two participants in the DB period discontinued study treatment during the DB period but remained in the study until its completion for safety follow-up. As they were no longer receiving the investigational product, they did not proceed into the LTSE period.
Participant milestones
| Measure |
Placebo + BZF 200 mg IR
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 200 mg IR
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Double-Blind Period (Up to 3 Years)
STARTED
|
19
|
19
|
19
|
18
|
|
Double-Blind Period (Up to 3 Years)
COMPLETED
|
17
|
17
|
18
|
14
|
|
Double-Blind Period (Up to 3 Years)
NOT COMPLETED
|
2
|
2
|
1
|
4
|
|
LTSE Period (From 3 Years to 5.4 Years)
STARTED
|
0
|
0
|
0
|
64
|
|
LTSE Period (From 3 Years to 5.4 Years)
COMPLETED
|
0
|
0
|
0
|
52
|
|
LTSE Period (From 3 Years to 5.4 Years)
NOT COMPLETED
|
0
|
0
|
0
|
12
|
Reasons for withdrawal
| Measure |
Placebo + BZF 200 mg IR
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 200 mg IR
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Double-Blind Period (Up to 3 Years)
Adverse Event
|
0
|
0
|
0
|
3
|
|
Double-Blind Period (Up to 3 Years)
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
|
Double-Blind Period (Up to 3 Years)
Inclusion/Exclusion Criteria
|
0
|
1
|
0
|
0
|
|
Double-Blind Period (Up to 3 Years)
Other
|
0
|
0
|
1
|
0
|
|
LTSE Period (From 3 Years to 5.4 Years)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
LTSE Period (From 3 Years to 5.4 Years)
Adverse Event
|
0
|
0
|
0
|
3
|
|
LTSE Period (From 3 Years to 5.4 Years)
Inclusion/Exclusion Criteria
|
0
|
0
|
0
|
1
|
|
LTSE Period (From 3 Years to 5.4 Years)
Other
|
0
|
0
|
0
|
5
|
|
LTSE Period (From 3 Years to 5.4 Years)
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Baseline characteristics by cohort
| Measure |
Placebo + BZF 200 mg IR
n=19 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of LSTE period, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=18 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 9.06 • n=9 Participants
|
55.9 years
STANDARD_DEVIATION 6.03 • n=27 Participants
|
53.7 years
STANDARD_DEVIATION 8.63 • n=267 Participants
|
55.1 years
STANDARD_DEVIATION 8.67 • n=265 Participants
|
55.4 years
STANDARD_DEVIATION 8.10 • n=568 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
70 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
69 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
67 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who had baseline and at least one post-baseline ALP assessment. Only those participants with data available at specified time points have been presented.
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP over time will be analyzed using a mixed model for repeated measures (MMRM) to assess treatment group effects across study visits. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from Baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=18 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=17 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period
|
-113.7 Units per liter (U/L)
Standard Error 11.07
|
-137.4 Units per liter (U/L)
Standard Error 15.40
|
-111.1 Units per liter (U/L)
Standard Error 11.41
|
-184.3 Units per liter (U/L)
Standard Error 16.37
|
SECONDARY outcome
Timeframe: Week 12Population: The Intent-to-Treat (ITT) Population included all randomized participants.
Responders were defined as participants achieving a ≥10%, ≥20%, ≥30%, or ≥40% reduction from baseline in serum ALP at Week 12 with non-responder imputation applied. Baseline ALP was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. The percentage of responders were summarized by treatment group for each response threshold and compared using a Cochran Mantel Haenszel test stratified by the randomization stratification factor.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=19 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=18 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
≥10% Reduction
|
100.0 percentage of participants
|
94.7 percentage of participants
|
94.7 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
≥20% Reduction
|
84.2 percentage of participants
|
94.7 percentage of participants
|
89.5 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
≥30% Reduction
|
78.9 percentage of participants
|
89.5 percentage of participants
|
78.9 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
≥40% Reduction
|
52.6 percentage of participants
|
78.9 percentage of participants
|
52.6 percentage of participants
|
88.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) Population
Percentage of participants achieving a response in serum ALP at Week 12 was assessed using non-responder imputation. Analyses of ALP response rates and normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=19 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=18 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Normalization Rates of ALP at Week 12 in the Double-Blind Treatment Period
Yes
|
47.4 percentage of participants
|
42.1 percentage of participants
|
21.1 percentage of participants
|
66.7 percentage of participants
|
|
Normalization Rates of ALP at Week 12 in the Double-Blind Treatment Period
No
|
52.6 percentage of participants
|
57.9 percentage of participants
|
78.9 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population. Only those participants with data available at specified timepoints have been presented.
Percentage of participants achieving a response in biochemical disease markers including Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), Total and conjugated Bilirubin and lipid panel (cholesterol, high density lipoprotein \[HDL\] and low-density lipoprotein \[LDL\]) at Week 12 has been presented. Analyses of response rates and normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=19 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=18 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
ALT, Normalization (yes)
|
84.2 percentage of participants
|
84.2 percentage of participants
|
77.8 percentage of participants
|
94.1 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
ALT, Normalization (no)
|
15.8 percentage of participants
|
15.8 percentage of participants
|
22.2 percentage of participants
|
5.9 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
GGT, Normalization (yes)
|
73.7 percentage of participants
|
47.4 percentage of participants
|
55.6 percentage of participants
|
58.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
GGT, Normalization (no)
|
26.3 percentage of participants
|
52.6 percentage of participants
|
44.4 percentage of participants
|
41.2 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
AST, Normalization (yes)
|
84.2 percentage of participants
|
88.9 percentage of participants
|
77.8 percentage of participants
|
82.4 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
AST, Normalization (no)
|
15.8 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
17.6 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Total bilirubin, Normalization (yes)
|
89.5 percentage of participants
|
89.5 percentage of participants
|
94.4 percentage of participants
|
100.0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Total bilirubin, Normalization (no)
|
10.5 percentage of participants
|
10.5 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Conjugated bilirubin, Normalization (yes)
|
94.1 percentage of participants
|
94.4 percentage of participants
|
94.1 percentage of participants
|
100.0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Conjugated bilirubin, Normalization (no
|
5.9 percentage of participants
|
5.6 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Cholesterol, Normalization (Yes)
|
57.9 percentage of participants
|
42.1 percentage of participants
|
33.3 percentage of participants
|
62.5 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Cholesterol, Normalization (No)
|
42.1 percentage of participants
|
57.9 percentage of participants
|
66.7 percentage of participants
|
37.5 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
HDL, Normalization (Yes)
|
84.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
HDL, Normalization (No)
|
15.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
LDL, Normalization (Yes)
|
21.1 percentage of participants
|
26.3 percentage of participants
|
11.8 percentage of participants
|
43.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
LDL, Normalization (No)
|
78.9 percentage of participants
|
73.7 percentage of participants
|
88.2 percentage of participants
|
56.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: ITT Population. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated timepoint and change from Baseline in GGT, ALT and AST were analyzed using the MMRM model and results were summarized in standard International System of Units (SI) by treatment group using descriptive statistics at baseline and at each on-study evaluation. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from baseline was calculated as post baseline value minus baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=18 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=17 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
GGT
|
-124.6 international units per liter (IU/L)
Standard Error 11.76
|
-97.3 international units per liter (IU/L)
Standard Error 14.71
|
-74.4 international units per liter (IU/L)
Standard Error 12.08
|
-163.1 international units per liter (IU/L)
Standard Error 15.60
|
|
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
ALT
|
-20.9 international units per liter (IU/L)
Standard Error 4.33
|
-1.2 international units per liter (IU/L)
Standard Error 5.71
|
-15.1 international units per liter (IU/L)
Standard Error 4.44
|
-17.8 international units per liter (IU/L)
Standard Error 6.04
|
|
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
AST
|
-10.7 international units per liter (IU/L)
Standard Error 3.73
|
1.4 international units per liter (IU/L)
Standard Error 4.73
|
-8.1 international units per liter (IU/L)
Standard Error 3.84
|
-7.5 international units per liter (IU/L)
Standard Error 5.00
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: ITT population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated timepoints and the changes in total and conjugated bilirubin were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from baseline was calculated as post baseline value minus baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=18 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=17 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Total and Conjugated Bilirubin in the Double-Blind Treatment Period
Total bilirubin
|
-1.8 micromoles per liter (µmol/L)
Standard Error 0.57
|
-1.2 micromoles per liter (µmol/L)
Standard Error 0.64
|
-1.2 micromoles per liter (µmol/L)
Standard Error 0.59
|
-2.9 micromoles per liter (µmol/L)
Standard Error 0.67
|
|
Change From Baseline in Total and Conjugated Bilirubin in the Double-Blind Treatment Period
Conjugated bilirubin
|
-0.4 micromoles per liter (µmol/L)
Standard Error 0.27
|
0.3 micromoles per liter (µmol/L)
Standard Error 0.39
|
-0.2 micromoles per liter (µmol/L)
Standard Error 0.26
|
-0.7 micromoles per liter (µmol/L)
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: ITT population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated timepoints and the changes in lipid panel including cholesterol, HDL and LDL were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from Baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=18 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=16 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
Cholesterol
|
-0.7 millimoles per liter (mmol/L)
Standard Error 0.15
|
-0.4 millimoles per liter (mmol/L)
Standard Error 0.17
|
-0.4 millimoles per liter (mmol/L)
Standard Error 0.15
|
-1.2 millimoles per liter (mmol/L)
Standard Error 0.18
|
|
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
HDL
|
-0.3 millimoles per liter (mmol/L)
Standard Error 0.07
|
0.1 millimoles per liter (mmol/L)
Standard Error 0.09
|
0.1 millimoles per liter (mmol/L)
Standard Error 0.08
|
-0.4 millimoles per liter (mmol/L)
Standard Error 0.09
|
|
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
LDL
|
-0.3 millimoles per liter (mmol/L)
Standard Error 0.10
|
-0.4 millimoles per liter (mmol/L)
Standard Error 0.13
|
-0.4 millimoles per liter (mmol/L)
Standard Error 0.11
|
-0.7 millimoles per liter (mmol/L)
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: The pharmacokinetic (PK) population included all participants who received OCA and/or BZF and had enough quantifiable PK samples without any major protocol deviations that could have potentially affect plasma exposure. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated timepoints for the assessment of C4. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as change equals post baseline value minus baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=18 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=18 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=16 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=17 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change From Baseline in 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4) in the Double-Blind Treatment Period
|
-13.799 Milligrams per deciliter (mg/dL)
Standard Deviation 12.117
|
-10.901 Milligrams per deciliter (mg/dL)
Standard Deviation 11.377
|
-4.871 Milligrams per deciliter (mg/dL)
Standard Deviation 8.369
|
-18.895 Milligrams per deciliter (mg/dL)
Standard Deviation 13.893
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected for the assessment of bile acids. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as change equals post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 200 mg IR
n=19 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
Placebo + BZF 400 mg SR
n=19 Participants
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
Placebo + BZF 200 mg IR
n=16 Participants
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
OCA 5 mg + BZF 400 mg SR
n=17 Participants
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Bile Acid in the Double-Blind Treatment Period
|
-4.732 micromoles per liter (µmol/L)
Standard Deviation 11.363
|
-4.512 micromoles per liter (µmol/L)
Standard Deviation 22.870
|
-1.088 micromoles per liter (µmol/L)
Standard Deviation 9.100
|
2.351 micromoles per liter (µmol/L)
Standard Deviation 10.687
|
Adverse Events
DB Period, Placebo + BZF 200 mg IR
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
DB Period, OCA 5 mg + BZF 200 mg IR
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
DB Period, Placebo + BZF 400 mg SR
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
DB Period, OCA 5 mg + BZF 400 mg SR
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
LTSE Period, OCA 5 mg + BZF 400 mg SR
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period, Placebo + BZF 200 mg IR
n=19 participants at risk
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
DB Period, OCA 5 mg + BZF 200 mg IR
n=19 participants at risk
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
DB Period, Placebo + BZF 400 mg SR
n=19 participants at risk
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
DB Period, OCA 5 mg + BZF 400 mg SR
n=18 participants at risk
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
LTSE Period, OCA 5 mg + BZF 400 mg SR
n=64 participants at risk
Participants received OCA 5 mg once daily in combination with BZF 400 mg SR tablets once daily.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
Other adverse events
| Measure |
DB Period, Placebo + BZF 200 mg IR
n=19 participants at risk
Participants received BZF 200 milligrams (mg) immediate-release (IR) tablets and a placebo BZF 400 mg sustained-release (SR) tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
DB Period, OCA 5 mg + BZF 200 mg IR
n=19 participants at risk
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 200 mg IR tablets once daily. To maintain blinding, participants also received a placebo BZF 400 mg SR tablet once daily.
|
DB Period, Placebo + BZF 400 mg SR
n=19 participants at risk
Participants received BZF 400 mg SR tablets and a placebo BZF 200 mg IR tablet once daily. To maintain blinding, participants also received a placebo OCA 5 mg tablet once daily from Weeks 0 to 4, followed by placebo OCA 10 mg once daily from Week 4 to the end of DB treatment once daily.
|
DB Period, OCA 5 mg + BZF 400 mg SR
n=18 participants at risk
Participants received OCA 5 mg once daily from Weeks 0 to 4, followed by OCA 10 mg once daily from Week 4 to the end of DB treatment, in combination with BZF 400 mg SR tablets once daily. To maintain blinding, participants also received a placebo BZF 200 mg IR tablet once daily.
|
LTSE Period, OCA 5 mg + BZF 400 mg SR
n=64 participants at risk
Participants received OCA 5 mg once daily in combination with BZF 400 mg SR tablets once daily.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
4.7%
3/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
21.1%
4/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
4.7%
3/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
6.2%
4/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
COVID-19
|
21.1%
4/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
21.1%
4/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
26.3%
5/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Eye infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Parvovirus B19 infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
6.2%
4/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
6.2%
4/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Ear infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
4/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
21.1%
4/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
9.4%
6/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Respiratory tract infection viral
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Rhinitis
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
4.7%
3/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Vulval abscess
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Wound infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
16.7%
3/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
4.7%
3/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
6.2%
4/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Radicular pain
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Sciatica
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
5/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
26.3%
5/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
26.3%
5/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
16.7%
3/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
18.8%
12/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Skin indentation
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
11.1%
2/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Bacterial test
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood triglycerides increased
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Transaminases increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
11.1%
2/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
6.2%
4/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
26.3%
5/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Dropped shoulder syndrome
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Fatigue
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
15.8%
3/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
4.7%
3/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Hot flush
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Vascular disorders
Peripheral venous disease
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Atrial fibrillation
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Chest discomfort
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Injection site irritation
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Injection site pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Medical device discomfort
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Vaccination site pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
10.5%
2/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Panic attack
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Reproductive system and breast disorders
Varicose veins pelvic
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Cataract
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Endocrine disorders
Polycystic ovarian syndrome
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Uveitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Social circumstances
Menopause
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Weight decreased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
7.8%
5/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Candida infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Ear, nose and throat infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Focal peritonitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Investigations
Fractional exhaled nitric oxide increased
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Hypothermia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Application site pruritus
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Asthenia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Malaise
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
General disorders
Peripheral swelling
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Hepatobiliary disorders
Liver tenderness
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Stress
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Sicca syndrome
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
3.1%
2/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Blepharitis
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
5.6%
1/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
1.6%
1/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
|
Psychiatric disorders
Nervousness
|
5.3%
1/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/19 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/18 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
0.00%
0/64 • DB Period: Up to Week 12; LTSE period: Up to Week 120.
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in the Safety Population. The Safety Population included all randomized participants who received at least 1 dose of BZF and/or OCA.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place